<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03237975</url>
  </required_header>
  <id_info>
    <org_study_id>BEYO Project-LYCUHK</org_study_id>
    <nct_id>NCT03237975</nct_id>
  </id_info>
  <brief_title>BEYO Project to Promote Sense of Coherence and Self-care of Elderly People With Type 2 Diabetes</brief_title>
  <acronym>BEYO</acronym>
  <official_title>A Strengths-based Intervention Based on Salutogenic Theory to Promote Sense of Coherence and Self-care of Elderly People With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Objectives of the Project&#xD;
&#xD;
           The BEYO project is designed based on the middle range theory of self-care of chronic&#xD;
           illness and salutogenic theory. The aim of this project is to facilitate self-care&#xD;
           behaviours of community-dwelling elderly patients with type 2 diabetes through promoting&#xD;
           SOC, and accordingly improve their health outcomes, including promoting quality of life&#xD;
           and reducing diabetes-related emotional distress.&#xD;
&#xD;
        2. Content of the Project&#xD;
&#xD;
      BEYO is a group-based consultation project. Each group contains 1 facilitator, 1 assistant&#xD;
      and 8 elderly patients. 5 weekly sessions are provided to let patients receive health&#xD;
      knowledge, discuss problems and experiences, explore available resources and build up goals&#xD;
      and solutions. Each session lasts for 40 minutes. Session 1 aims to build social network&#xD;
      among group members and introduce group goals and tasks. Session 2-4 covers six topics based&#xD;
      on the Chinese guideline for type 2 diabetes released by Chinese diabetes society: (i)&#xD;
      healthy dietary, (ii) exercise and activity, (iii) taking medication, (iv) blood glucose&#xD;
      monitoring, (v) reducing risks for complication, (vi) healthy coping with mental stress.&#xD;
      These middle sessions execute a common session flow to construct an action plan utilizing&#xD;
      patients' resources and strengths to achieve the client-centered goal. Session 5 aims to&#xD;
      review the process, summarize effective solutions, and set up plans for the future. One-week,&#xD;
      one-month and three-month telephone follow-ups are delivered to help patients solve problems&#xD;
      encountered during implementing the action plan and evaluate their self-care, SOC and other&#xD;
      health outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Overall aims The aim of this study is to develop and evaluate the effects of a&#xD;
           strengths-based group intervention called Be the Expert for Your Own (BEYO) among&#xD;
           elderly patients with type 2 diabetes to facilitate their SOC and self-care, and&#xD;
           accordingly improve their health outcomes.&#xD;
&#xD;
        2. Study Design This study is designed to be a mixed method research incorporating both&#xD;
           quantitative and qualitative components. A two-arm randomized controlled trial (RCT)&#xD;
           will be conducted to assess the effects of a strengths-based group intervention compared&#xD;
           with routine health education on SOC and self-care of elderly people with type 2&#xD;
           diabetes. The theoretical framework for BEYO program is based on salutogenic theory&#xD;
           proposed by Antonovsky (1987). Qualitative study will be conducted at the end of the&#xD;
           program to explore patients' experience about BEYO and the mechanism through which BEYO&#xD;
           can facilitate self-care, in terms of what component and how.&#xD;
&#xD;
      2. Be the Expert for Your Own (BEYO) program&#xD;
&#xD;
        1. Overview The BEYO protocol consists of 5 structured sessions among intervention&#xD;
           facilitator and 8 type 2 diabetes patients.The common flow for structured sessions&#xD;
           contains 7 steps. Rationale and aims for designing each step are described as follows.&#xD;
&#xD;
           Step 1 - &quot;Health education&quot; As supported by the middle range theory and results from&#xD;
           integrated review, knowledge acquisition is essential among patients with chronic&#xD;
           disease to perform reflective, sufficient and reasoned self-care actions with a pattern.&#xD;
           This step aims to equip patients with basic knowledge and essential skills to manage&#xD;
           their disease.&#xD;
&#xD;
           Step 2 - &quot;Discuss self-care experience and identify deficit&quot; This step aims to collect&#xD;
           basic information about clients' experience of performing self-care in each specific&#xD;
           area and identify major problems they encounter in this process. This step facilitates&#xD;
           information exchange and experience sharing among clients and provides reference for&#xD;
           intervention facilitator about clients' basic situation. Besides, giving enough&#xD;
           opportunity to describe the problem makes it easier to redirect the conversation later&#xD;
           if attendees restart talking about the problem.&#xD;
&#xD;
           Step 3 - &quot;Describe exceptions&quot; One of the central beliefs for SFT is that there are&#xD;
           always exceptions to problems. There are always times and situations when the problem&#xD;
           occurs less or when the client feels like successfully managing even a slight part of&#xD;
           the problem. After identifying self-care deficit, clients are asked to describe these&#xD;
           exceptional times in this step to help them find out skills, resources, and strengths at&#xD;
           their disposal. The close attention for exceptions improves clients' sense of&#xD;
           self-mastery and their ability to plan further steps.&#xD;
&#xD;
           Step 4 - &quot;Identify the strengths&quot; On the basis of review and analysis for exceptions, it&#xD;
           is the right time to list out and summarize clients' strengths revealed in these&#xD;
           exceptions. This step lays a foundation for establishing solutions later, for that&#xD;
           detected strengths can be amplified and repeated to ultimately dismantle the problem.&#xD;
&#xD;
           Step 5 - &quot;Miracle question and scaling&quot; The miracle question is a common tool in SFT as&#xD;
           a way to build clear, client-centered and practical goals. Scaling questions help to&#xD;
           break the goal down into small manageable steps that can be carried out in the short&#xD;
           term. This step helps clients find out what they want to achieve through this program.&#xD;
           Setting the goal by themselves facilitates an empowering and optimistic experience for&#xD;
           clients that promoting goal-focused thinking during the self-care process and&#xD;
           highlighting their responsibility for the future actions.&#xD;
&#xD;
           Step 6 - &quot;Establish the solution&quot; After exploring strengths and setting up the goal,&#xD;
           this step aims to link strengths and goals together to establish the solution. As the&#xD;
           basic principles for SFT is focusing on strengths rather than weakness, resources rather&#xD;
           than deficits, the created solution is more concerned with achievement than with solving&#xD;
           problems, with hoping not just coping. It helps clients move forward in their lives.&#xD;
&#xD;
           Step 7 - &quot;Action plan&quot; As the final step, a structured action plan is generated to&#xD;
           transform the solution into arranged tasks. The action plan guides the behaviors of the&#xD;
           clients and tracks the progress of implementation.&#xD;
&#xD;
        2. The role of facilitator Different with the traditional teacher-centered didactic model,&#xD;
           facilitators in BEYO program need to get out of the expert role and appreciate patients'&#xD;
           capabilities from the aspect of truly human beings. Rather than being at the center of&#xD;
           the group, the facilitator is a supporter to assist patients to identify what they want&#xD;
           to achieve, to help them to think about strengths and resources during the group&#xD;
           interactions, to build up solutions for their own situations and to make plans to reach&#xD;
           the goal step by step.&#xD;
&#xD;
           To build a hope-inducing relationship between the facilitator and clients has been&#xD;
           emphasized as the context for practice to enhance the effectiveness of strengths-based&#xD;
           techniques (Fischer, 1978). The foundation for a hope-inducing relationship includes&#xD;
           empathy, genuineness and unconditional positive regard (Maluccio, 1979). To be empathy,&#xD;
           facilitators need to perceive and communicate feelings of attendees with sensitivity,&#xD;
           and think about the meaning of these feelings. Genuineness means that facilitators&#xD;
           should be themselves in the helping process rather than presenting a professional&#xD;
           facade. Unconditional positive regard asks facilitators to give positive feedback to&#xD;
           every good change and to express the respect, acceptance, caring and concern for the&#xD;
           client in a non-dominating way.&#xD;
&#xD;
        3. Objectives for each session Session 1 aims to build social network among group members&#xD;
           and make clients feel welcome. Group goals and task will be introduced to gel the&#xD;
           clients around the group.&#xD;
&#xD;
           Session 2-4 execute a common session flow to finally construct an action plan to achieve&#xD;
           the client-centered goal. Themes for the total 3 sessions respectively cover the six&#xD;
           areas as mentioned earlier. Except session 2, all the other sessions will start with&#xD;
           reinforcing the positive change happening since the last session.&#xD;
&#xD;
           Session 5 aims to celebrate the achievement, review the process, summarize clients'&#xD;
           strengths and effective solutions, and set up plans for the future.&#xD;
&#xD;
        4. Acceptability and feasibility evaluation Researchers will record numbers and proportions&#xD;
           for recruitment, consent, attendance, and attrition rate. Duration of sessions and&#xD;
           intervention activities will be recorded using field notes. The research team and the&#xD;
           facilitator will discuss the delivery of the program and study progress every week.&#xD;
&#xD;
      The focus-group interview will be conducted at the end of the study to explore patients'&#xD;
      experience and opinions about the content and process, and barriers and enablers to&#xD;
      compliance with the intervention.&#xD;
&#xD;
      3. Subjects&#xD;
&#xD;
      3.1 Sampling and recruitment The group of elderly patients with type 2 diabetes living in&#xD;
      Changsha, a city in central China, is selected as the study population. Multi-stage random&#xD;
      sampling will be used to recruit community-dwelling participants. First, two of the five&#xD;
      municipal districts of Changsha City based on present administrative system will be randomly&#xD;
      selected. Second, detailed information including names and numbers of community health&#xD;
      service centers belong to each district can be achieved through government official websites.&#xD;
      Two community health service centers respectively belong to the two districts will be&#xD;
      randomly selected. Third, based on national standards of public health services, all the&#xD;
      community-dwelling patients with type 2 diabetes should be recorded in the electronic medical&#xD;
      system charged by the department of chronic disease management in the community health&#xD;
      service center. Random number table method will be used to select potential participants in&#xD;
      each of the two communities, using this electronic system. No private information of type 2&#xD;
      diabetes patients will be retrieved except for their name, mailing address and contact&#xD;
      number.&#xD;
&#xD;
      An information sheet will be sent as a letter from the research team to the potential&#xD;
      participant followed by a telephone call two days later. The phone call is mainly designed to&#xD;
      (i) further make sure if the referrals meet the inclusion criteria, such as age and time of&#xD;
      diagnosis; (ii) discuss the information sheet and obtain verbal informed consent for the&#xD;
      project, (iii) verbally deliver Abbreviated Mental Test (AMT) and the Summary of Diabetes&#xD;
      Self-Care Activities measure (SDSCA) to make sure the participants have intact cognitive&#xD;
      function and experience at least some degree of self-care deficit for diabetes.&#xD;
&#xD;
      3.2 Sample size calculation The significance level and the power are set at 5% and 80%&#xD;
      respectively. The primary outcome is self-care of elderly patients with type 2 diabetes.&#xD;
      However, based on the result of literature review, no previous studies used strengths-based&#xD;
      intervention reported its effects on self-care. Based on the result of a meta-analysis&#xD;
      assessing effects of group-based diabetes self-management education compared to routine&#xD;
      treatment (Steinsbekk, Rygg, Lisulo, Rise, &amp; Fretheim, 2012), the standardized mean&#xD;
      difference for self-care skills was 0.55. Thus, a sample size of 53 in each group is enough&#xD;
      to detect the difference in the means of self-care between two groups. Allowing for a dropout&#xD;
      rate of 20%, a total of 132 participants will be required.&#xD;
&#xD;
      3.3 Randomization After obtaining the signed informed consent form and collecting the&#xD;
      baseline data, patients will be randomly allocated to the intervention or control group,&#xD;
      using a computerized permuted block randomization with concealment.&#xD;
&#xD;
      4. Data Collection Data collection will be commenced after receiving written informed consent&#xD;
      voluntarily signed by participants. The baseline information (T0) will be collected before&#xD;
      the randomization. After completing the intervention or control protocol, a follow-up data&#xD;
      collection (T1) will be conducted immediately by a group of trained research assistants, who&#xD;
      are blinded to the participants' group assignment and workshop attendance. Repeated data&#xD;
      collection (T2) will take place at 3 months after the completion of the strength-based&#xD;
      intervention by the same group of research assistants.&#xD;
&#xD;
      5. Data Analysis Plan Invalid questionnaire (questionnaire with obvious logic error, or with&#xD;
      more than 20% unanswered questions) will be excluded before put into the database. SPSS&#xD;
      version 22.0 will be used to process data. The level of statistical significance will be set&#xD;
      at 0.05. Q-Q plot, Skewness and Kurtosis will be used to examine the normality of continuous&#xD;
      data. Descriptive statistics will be used to summarize the demographic characteristics,&#xD;
      health status and patient-centered outcomes. The effectiveness of the intervention will be&#xD;
      assessed based on the intention-to-treat (ITT) principle. The generalized estimating equation&#xD;
      (GEE) model will be used to estimate the intervention effect over time. Hierarchical multiple&#xD;
      regression analysis will be conducted to examine the mediating effect of sense of coherence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants were assigned to two groups in parallel for the duration of the study. One group received usual care for diabetes patients. One group received strengths-based intervention.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the Chinese version of the Summary of Diabetes Self-Care Activities measure (SDSCA)</measure>
    <time_frame>From the date of recruitment, until the date of randomization, up to 2 weeks</time_frame>
    <description>SDSCA is a brief self-report measure for assessing levels of self-care across different components of the diabetes regimen. The new version revised by Toobert's team (2000) uses 11 items to include 6 aspects of diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short form of the sense of coherence questionnaire (SOC-13)</measure>
    <time_frame>From the date of recruitment, until the date of randomization, up to 2 weeks</time_frame>
    <description>The SOC questionnaire was developed by Antonovsky (1987) to measure three components of sense of coherence: comprehensibility, manageability and meaningfulness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the Chinese version of the Summary of Diabetes Self-Care Activities measure (SDSCA)</measure>
    <time_frame>5 weeks after the project started</time_frame>
    <description>SDSCA is a brief self-report measure for assessing levels of self-care across different components of the diabetes regimen. The new version revised by Toobert's team (2000) uses 11 items to include 6 aspects of diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short form of the sense of coherence questionnaire (SOC-13)</measure>
    <time_frame>5 weeks after the project started</time_frame>
    <description>The SOC questionnaire was developed by Antonovsky (1987) to measure three components of sense of coherence: comprehensibility, manageability and meaningfulness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the Chinese version of the Summary of Diabetes Self-Care Activities measure (SDSCA)</measure>
    <time_frame>3-month after the project ended</time_frame>
    <description>SDSCA is a brief self-report measure for assessing levels of self-care across different components of the diabetes regimen. The new version revised by Toobert's team (2000) uses 11 items to include 6 aspects of diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short form of the sense of coherence questionnaire (SOC-13)</measure>
    <time_frame>3-month after the project ended</time_frame>
    <description>The SOC questionnaire was developed by Antonovsky (1987) to measure three components of sense of coherence: comprehensibility, manageability and meaningfulness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the Chinese version of the Audit of Diabetes Dependent Quality of Life (CN-ADDQoL)</measure>
    <time_frame>From the date of recruitment, until the date of randomization, up to 2 weeks; 5 weeks after the project started; 3-month after the project ended</time_frame>
    <description>The ADDQoL is a diabetes-specific health related quality of life instrument (Bradley et al., 1999) assessed perceived impact of diabetes on 19 life domains containing physical functioning, symptoms, psychological well-being, social well-being, role activities and personal construct.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Distress Scale (DDS)</measure>
    <time_frame>From the date of recruitment, until the date of randomization, up to 2 weeks; 5 weeks after the project started; 3-month after the project ended</time_frame>
    <description>The DDS is developed by Polonsky et al (2005) to assess diabetes-related emotional distress. DDS contains 17 items to cover 4 dimensions: emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Self-Efficacy Scale (DSES)</measure>
    <time_frame>From the date of recruitment, until the date of randomization, up to 2 weeks; 5 weeks after the project started, 3-month after the project ended</time_frame>
    <description>DSES was developed by Stanford Patient Education Research Center (Lorig et al., 2009), including 8 items to assess patients' confidence in areas including dietary, exercise and symptom management.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Sense of Coherence</condition>
  <condition>Self Care</condition>
  <condition>Strengths-based Intervention</condition>
  <arm_group>
    <arm_group_label>Be the Expert for Your Own (BEYO)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BEYO is a group-based consultation project. Each group contains 1 facilitator, 1 assistant and 8 elderly patients. 5 weekly sessions are provided to let patients receive health knowledge, discuss problems and experiences, explore available resources and build up goals and solutions. Each session lasts for 40 minutes. Session 1 aims to build social network among group members and introduce group goals and tasks. Session 2-4 covers six topics: (i) healthy dietary, (ii) exercise and activity, (iii) taking medication, (iv) blood glucose monitoring, (v) reducing risks for complication, (vi) healthy coping with mental stress. Session 5 aims to review the process, summarize effective solutions, and set up plans for the future.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine health education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To neutralize the effect of extra attention from the facilitator, participants in control group will receive routine health education on topics related to type 2 diabetes. Contents for the routine education will be based on the national guideline of basic public health service for diabetes and specific implementation protocols in each community. Participants in control group will receive 5-weekly education packet at the same time with participants in intervention group. The patients will not be given any strengths-based information, but they are free to discuss their disease status with nurses or physicians at their regular follow-up appointments.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Be the Expert for Your Own (BEYO)</intervention_name>
    <description>The BEYO program is structured adopting solution focused therapy (SFT). The basic principles for SFT are focusing on positive change and establishing groups driven by goals rather than problems. Solutions are generated through searching for strengths, skills, resources that working in clients' lives.&#xD;
The common flow for structured sessions contains 7 steps: 1) Health education; 2) Discuss self-care experience and identify deficit; 3) Describe exceptions; 4) Identify the strengths; 5) Miracle question and scaling; 6) Establish the solution; 7) Action plan.</description>
    <arm_group_label>Be the Expert for Your Own (BEYO)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Routine health education</intervention_name>
    <description>The control group will receive routine health education.</description>
    <arm_group_label>Routine health education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A medical diagnosis of type 2 diabetes according to diagnostic criteria recommended by&#xD;
             WHO (2006);&#xD;
&#xD;
          2. Older than aged 60 years;&#xD;
&#xD;
          3. Diagnosed with diabetes at least six months before the intervention;&#xD;
&#xD;
          4. Residing in the community, able to read and communicate in Chinese;&#xD;
&#xD;
          5. Having intact cognitive function as indicated by the Abbreviated Mental Test of score&#xD;
             &gt;=6;&#xD;
&#xD;
          6. Having some degree of self-care deficit as indicated by the Chinese version of SDSCA&#xD;
             of score &lt;=23.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of serious mental problem or terminal illness;&#xD;
&#xD;
          2. Previously participated in similar programs;&#xD;
&#xD;
          3. Visual or audio impaired.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yang Lei</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>He Xinyuan Community Health Care Center</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yannong Neighborhood Health Care Clinics</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Lei Yang</investigator_full_name>
    <investigator_title>Graduate Assistant</investigator_title>
  </responsible_party>
  <keyword>type 2 diabetes</keyword>
  <keyword>sense of coherence</keyword>
  <keyword>self-care</keyword>
  <keyword>strengths-based intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03237975
org study id: BEYO Project-LYCUHK
nct id: NCT03237975
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
1. Objectives of the Project

           The BEYO project is designed based on the middle range theory of self-care of chronic
           illness and salutogenic theory. The aim of this project is to facilitate self-care
           behaviours of community-dwelling elderly patients with type 2 diabetes through promoting
           SOC, and accordingly improve their health outcomes, including promoting quality of life
           and reducing diabetes-related emotional distress.

        2. Content of the Project

      BEYO is a group-based consultation project. Each group contains 1 facilitator, 1 assistant
      and 8 elderly patients. 5 weekly sessions are provided to let patients receive health
      knowledge, discuss problems and experiences, explore available resources and build up goals
      and solutions. Each session lasts for 40 minutes. Session 1 aims to build social network
      among group members and introduce group goals and tasks. Session 2-4 covers six topics based
      on the Chinese guideline for type 2 diabetes released by Chinese diabetes society: (i)
      healthy dietary, (ii) exercise and activity, (iii) taking medication, (iv) blood glucose
      monitoring, (v) reducing risks for complication, (vi) healthy coping with mental stress.
      These middle sessions execute a common session flow to construct an action plan utilizing
      patients' resources and strengths to achieve the client-centered goal. Session 5 aims to
      review the process, summarize effective solutions, and set up plans for the future. One-week,
      one-month and three-month telephone follow-ups are delivered to help patients solve problems
      encountered during implementing the action plan and evaluate their self-care, SOC and other
      health outcomes.
1. Overall aims The aim of this study is to develop and evaluate the effects of a
           strengths-based group intervention called Be the Expert for Your Own (BEYO) among
           elderly patients with type 2 diabetes to facilitate their SOC and self-care, and
           accordingly improve their health outcomes.

        2. Study Design This study is designed to be a mixed method research incorporating both
           quantitative and qualitative components. A two-arm randomized controlled trial (RCT)
           will be conducted to assess the effects of a strengths-based group intervention compared
           with routine health education on SOC and self-care of elderly people with type 2
           diabetes. The theoretical framework for BEYO program is based on salutogenic theory
           proposed by Antonovsky (1987). Qualitative study will be conducted at the end of the
           program to explore patients' experience about BEYO and the mechanism through which BEYO
           can facilitate self-care, in terms of what component and how.

      2. Be the Expert for Your Own (BEYO) program

        1. Overview The BEYO protocol consists of 5 structured sessions among intervention
           facilitator and 8 type 2 diabetes patients.The common flow for structured sessions
           contains 7 steps. Rationale and aims for designing each step are described as follows.

           Step 1 - "Health education" As supported by the middle range theory and results from
           integrated review, knowledge acquisition is essential among patients with chronic
           disease to perform reflective, sufficient and reasoned self-care actions with a pattern.
           This step aims to equip patients with basic knowledge and essential skills to manage
           their disease.

           Step 2 - "Discuss self-care experience and identify deficit" This step aims to collect
           basic information about clients' experience of performing self-care in each specific
           area and identify major problems they encounter in this process. This step facilitates
           information exchange and experience sharing among clients and provides reference for
           intervention facilitator about clients' basic situation. Besides, giving enough
           opportunity to describe the problem makes it easier to redirect the conversation later
           if attendees restart talking about the problem.

           Step 3 - "Describe exceptions" One of the central beliefs for SFT is that there are
           always exceptions to problems. There are always times and situations when the problem
           occurs less or when the client feels like successfully managing even a slight part of
           the problem. After identifying self-care deficit, clients are asked to describe these
           exceptional times in this step to help them find out skills, resources, and strengths at
           their disposal. The close attention for exceptions improves clients' sense of
           self-mastery and their ability to plan further steps.

           Step 4 - "Identify the strengths" On the basis of review and analysis for exceptions, it
           is the right time to list out and summarize clients' strengths revealed in these
           exceptions. This step lays a foundation for establishing solutions later, for that
           detected strengths can be amplified and repeated to ultimately dismantle the problem.

           Step 5 - "Miracle question and scaling" The miracle question is a common tool in SFT as
           a way to build clear, client-centered and practical goals. Scaling questions help to
           break the goal down into small manageable steps that can be carried out in the short
           term. This step helps clients find out what they want to achieve through this program.
           Setting the goal by themselves facilitates an empowering and optimistic experience for
           clients that promoting goal-focused thinking during the self-care process and
           highlighting their responsibility for the future actions.

           Step 6 - "Establish the solution" After exploring strengths and setting up the goal,
           this step aims to link strengths and goals together to establish the solution. As the
           basic principles for SFT is focusing on strengths rather than weakness, resources rather
           than deficits, the created solution is more concerned with achievement than with solving
           problems, with hoping not just coping. It helps clients move forward in their lives.

           Step 7 - "Action plan" As the final step, a structured action plan is generated to
           transform the solution into arranged tasks. The action plan guides the behaviors of the
           clients and tracks the progress of implementation.

        2. The role of facilitator Different with the traditional teacher-centered didactic model,
           facilitators in BEYO program need to get out of the expert role and appreciate patients'
           capabilities from the aspect of truly human beings. Rather than being at the center of
           the group, the facilitator is a supporter to assist patients to identify what they want
           to achieve, to help them to think about strengths and resources during the group
           interactions, to build up solutions for their own situations and to make plans to reach
           the goal step by step.

           To build a hope-inducing relationship between the facilitator and clients has been
           emphasized as the context for practice to enhance the effectiveness of strengths-based
           techniques (Fischer, 1978). The foundation for a hope-inducing relationship includes
           empathy, genuineness and unconditional positive regard (Maluccio, 1979). To be empathy,
           facilitators need to perceive and communicate feelings of attendees with sensitivity,
           and think about the meaning of these feelings. Genuineness means that facilitators
           should be themselves in the helping process rather than presenting a professional
           facade. Unconditional positive regard asks facilitators to give positive feedback to
           every good change and to express the respect, acceptance, caring and concern for the
           client in a non-dominating way.

        3. Objectives for each session Session 1 aims to build social network among group members
           and make clients feel welcome. Group goals and task will be introduced to gel the
           clients around the group.

           Session 2-4 execute a common session flow to finally construct an action plan to achieve
           the client-centered goal. Themes for the total 3 sessions respectively cover the six
           areas as mentioned earlier. Except session 2, all the other sessions will start with
           reinforcing the positive change happening since the last session.

           Session 5 aims to celebrate the achievement, review the process, summarize clients'
           strengths and effective solutions, and set up plans for the future.

        4. Acceptability and feasibility evaluation Researchers will record numbers and proportions
           for recruitment, consent, attendance, and attrition rate. Duration of sessions and
           intervention activities will be recorded using field notes. The research team and the
           facilitator will discuss the delivery of the program and study progress every week.

      The focus-group interview will be conducted at the end of the study to explore patients'
      experience and opinions about the content and process, and barriers and enablers to
      compliance with the intervention.

      3. Subjects

      3.1 Sampling and recruitment The group of elderly patients with type 2 diabetes living in
      Changsha, a city in central China, is selected as the study population. Multi-stage random
      sampling will be used to recruit community-dwelling participants. First, two of the five
      municipal districts of Changsha City based on present administrative system will be randomly
      selected. Second, detailed information including names and numbers of community health
      service centers belong to each district can be achieved through government official websites.
      Two community health service centers respectively belong to the two districts will be
      randomly selected. Third, based on national standards of public health services, all the
      community-dwelling patients with type 2 diabetes should be recorded in the electronic medical
      system charged by the department of chronic disease management in the community health
      service center. Random number table method will be used to select potential participants in
      each of the two communities, using this electronic system. No private information of type 2
      diabetes patients will be retrieved except for their name, mailing address and contact
      number.

      An information sheet will be sent as a letter from the research team to the potential
      participant followed by a telephone call two days later. The phone call is mainly designed to
      (i) further make sure if the referrals meet the inclusion criteria, such as age and time of
      diagnosis; (ii) discuss the information sheet and obtain verbal informed consent for the
      project, (iii) verbally deliver Abbreviated Mental Test (AMT) and the Summary of Diabetes
      Self-Care Activities measure (SDSCA) to make sure the participants have intact cognitive
      function and experience at least some degree of self-care deficit for diabetes.

      3.2 Sample size calculation The significance level and the power are set at 5% and 80%
      respectively. The primary outcome is self-care of elderly patients with type 2 diabetes.
      However, based on the result of literature review, no previous studies used strengths-based
      intervention reported its effects on self-care. Based on the result of a meta-analysis
      assessing effects of group-based diabetes self-management education compared to routine
      treatment (Steinsbekk, Rygg, Lisulo, Rise, & Fretheim, 2012), the standardized mean
      difference for self-care skills was 0.55. Thus, a sample size of 53 in each group is enough
      to detect the difference in the means of self-care between two groups. Allowing for a dropout
      rate of 20%, a total of 132 participants will be required.

      3.3 Randomization After obtaining the signed informed consent form and collecting the
      baseline data, patients will be randomly allocated to the intervention or control group,
      using a computerized permuted block randomization with concealment.

      4. Data Collection Data collection will be commenced after receiving written informed consent
      voluntarily signed by participants. The baseline information (T0) will be collected before
      the randomization. After completing the intervention or control protocol, a follow-up data
      collection (T1) will be conducted immediately by a group of trained research assistants, who
      are blinded to the participants' group assignment and workshop attendance. Repeated data
      collection (T2) will take place at 3 months after the completion of the strength-based
      intervention by the same group of research assistants.

      5. Data Analysis Plan Invalid questionnaire (questionnaire with obvious logic error, or with
      more than 20% unanswered questions) will be excluded before put into the database. SPSS
      version 22.0 will be used to process data. The level of statistical significance will be set
      at 0.05. Q-Q plot, Skewness and Kurtosis will be used to examine the normality of continuous
      data. Descriptive statistics will be used to summarize the demographic characteristics,
      health status and patient-centered outcomes. The effectiveness of the intervention will be
      assessed based on the intention-to-treat (ITT) principle. The generalized estimating equation
      (GEE) model will be used to estimate the intervention effect over time. Hierarchical multiple
      regression analysis will be conducted to examine the mediating effect of sense of coherence.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were assigned to two groups in parallel for the duration of the study. One group received usual care for diabetes patients. One group received strengths-based intervention.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: the Chinese version of the Summary of Diabetes Self-Care Activities measure (SDSCA)
time frame: From the date of recruitment, until the date of randomization, up to 2 weeks
description: SDSCA is a brief self-report measure for assessing levels of self-care across different components of the diabetes regimen. The new version revised by Toobert's team (2000) uses 11 items to include 6 aspects of diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.
measure: Short form of the sense of coherence questionnaire (SOC-13)
time frame: From the date of recruitment, until the date of randomization, up to 2 weeks
description: The SOC questionnaire was developed by Antonovsky (1987) to measure three components of sense of coherence: comprehensibility, manageability and meaningfulness.
measure: the Chinese version of the Summary of Diabetes Self-Care Activities measure (SDSCA)
time frame: 5 weeks after the project started
description: SDSCA is a brief self-report measure for assessing levels of self-care across different components of the diabetes regimen. The new version revised by Toobert's team (2000) uses 11 items to include 6 aspects of diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.
measure: Short form of the sense of coherence questionnaire (SOC-13)
time frame: 5 weeks after the project started
description: The SOC questionnaire was developed by Antonovsky (1987) to measure three components of sense of coherence: comprehensibility, manageability and meaningfulness.
measure: the Chinese version of the Summary of Diabetes Self-Care Activities measure (SDSCA)
time frame: 3-month after the project ended
description: SDSCA is a brief self-report measure for assessing levels of self-care across different components of the diabetes regimen. The new version revised by Toobert's team (2000) uses 11 items to include 6 aspects of diabetes regimen: general diet, specific diet, exercise, blood-glucose testing, foot care, and smoking.
measure: Short form of the sense of coherence questionnaire (SOC-13)
time frame: 3-month after the project ended
description: The SOC questionnaire was developed by Antonovsky (1987) to measure three components of sense of coherence: comprehensibility, manageability and meaningfulness.
measure: the Chinese version of the Audit of Diabetes Dependent Quality of Life (CN-ADDQoL)
time frame: From the date of recruitment, until the date of randomization, up to 2 weeks; 5 weeks after the project started; 3-month after the project ended
description: The ADDQoL is a diabetes-specific health related quality of life instrument (Bradley et al., 1999) assessed perceived impact of diabetes on 19 life domains containing physical functioning, symptoms, psychological well-being, social well-being, role activities and personal construct.
measure: Diabetes Distress Scale (DDS)
time frame: From the date of recruitment, until the date of randomization, up to 2 weeks; 5 weeks after the project started; 3-month after the project ended
description: The DDS is developed by Polonsky et al (2005) to assess diabetes-related emotional distress. DDS contains 17 items to cover 4 dimensions: emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal distress.
measure: Diabetes Self-Efficacy Scale (DSES)
time frame: From the date of recruitment, until the date of randomization, up to 2 weeks; 5 weeks after the project started, 3-month after the project ended
description: DSES was developed by Stanford Patient Education Research Center (Lorig et al., 2009), including 8 items to assess patients' confidence in areas including dietary, exercise and symptom management.
arm group label: Be the Expert for Your Own (BEYO)
arm group type: Experimental
description: BEYO is a group-based consultation project. Each group contains 1 facilitator, 1 assistant and 8 elderly patients. 5 weekly sessions are provided to let patients receive health knowledge, discuss problems and experiences, explore available resources and build up goals and solutions. Each session lasts for 40 minutes. Session 1 aims to build social network among group members and introduce group goals and tasks. Session 2-4 covers six topics: (i) healthy dietary, (ii) exercise and activity, (iii) taking medication, (iv) blood glucose monitoring, (v) reducing risks for complication, (vi) healthy coping with mental stress. Session 5 aims to review the process, summarize effective solutions, and set up plans for the future.
arm group label: Routine health education
arm group type: Active Comparator
description: To neutralize the effect of extra attention from the facilitator, participants in control group will receive routine health education on topics related to type 2 diabetes. Contents for the routine education will be based on the national guideline of basic public health service for diabetes and specific implementation protocols in each community. Participants in control group will receive 5-weekly education packet at the same time with participants in intervention group. The patients will not be given any strengths-based information, but they are free to discuss their disease status with nurses or physicians at their regular follow-up appointments.
intervention type: Behavioral
intervention name: Be the Expert for Your Own (BEYO)
description: The BEYO program is structured adopting solution focused therapy (SFT). The basic principles for SFT are focusing on positive change and establishing groups driven by goals rather than problems. Solutions are generated through searching for strengths, skills, resources that working in clients' lives.
The common flow for structured sessions contains 7 steps: 1) Health education; 2) Discuss self-care experience and identify deficit; 3) Describe exceptions; 4) Identify the strengths; 5) Miracle question and scaling; 6) Establish the solution; 7) Action plan.
arm group label: Be the Expert for Your Own (BEYO)
intervention type: Other
intervention name: Routine health education
description: The control group will receive routine health education.
arm group label: Routine health education
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Yang Lei
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Lei Yang
investigator title: Graduate Assistant
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2