<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/NCT03783598</url>
  </required_header>
  <id_info>
    <org_study_id>569831°</org_study_id>
    <nct_id>NCT03783598</nct_id>
  </id_info>
  <brief_title>Person-Centered, Occupation Based Therapy for Type 2 Diabetes</brief_title>
  <official_title>Person-Centered, Occupation Based Intervention Program Supported With Problem-Solving Therapy for Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uskudar University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Uskudar University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study was conducted to investigate the effect of a person-centered, occupation-based&#xD;
      intervention program supported with problem-solving strategy in individuals with type 2&#xD;
      diabetes (T2D).&#xD;
&#xD;
      Method: The study was a randomized controlled trial, that included intervention (n=33) and&#xD;
      control group (n=34), between the ages of 18 and 65 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It was planned as a single-blind, randomized controlled study with 3-month follow-up in&#xD;
      adults. A total of 67 subjects were randomly allocated to the intervention (n=33) or the&#xD;
      control group (n=34). This program prepared with consider to meaningful activities for&#xD;
      individual and overcome to barriers via problem solving. That was designed as 6 modules&#xD;
      including evaluations, diabetes education and problem-solving therapy. Each module was&#xD;
      implemented at least 1 session per week, about 60 minutes, and was arranged according to&#xD;
      individual needs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2015</start_date>
  <completion_date type="Actual">March 27, 2018</completion_date>
  <primary_completion_date type="Actual">February 2, 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>The problem solving therapy is an social cognitive therapy approach. And ıt support to solve meaningfull occupational performance problems realted to diabetes by invdividuals and this way, it helps to improve the self-management of diabetes.We used that with person centered perspective and support to person with education which was perspective of person environment occupation model.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The study population was 76 individuals whose diagnosis of type 2 diabetes. 9 volunteer individual gave up to participation without for various reasons in the process.That intervention grup (n=33) control group (n=34), between the ages of 18 to 65 years and volunteer individuals.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Canada activity performance measure (COPM)</measure>
    <time_frame>Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.</time_frame>
    <description>COPM, measure self-perceived change in problem on occupational performance and satisfaction over time. The COPM enable individuals to identify and prioritize everyday issues that restrict or impact their performance in everyday living. In the first step, occupational therapist interviews with client determine what the individual has done in his/her routine, what he/she wants to do or can not to do in their self-care, productivity and free time. Secondly the client to rate, on a scale of 1 to 10, the importance of each activity. Then confirming with the client the 5 most important problems and record. The client to rate each problem on performance and satisfaction, then calculate the total scores.&#xD;
Total scores are calculated by adding together the performance or satisfaction scores for all problems and dividing by the number of problems. At reassessment,the client scores each problem again for performance and satisfaction. Calculate the new scores and the change score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The diabetes empowerment scale (DES)</measure>
    <time_frame>Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.</time_frame>
    <description>DES measure the psychosocial self-efficacy of people with diabetes. The scale consists of three factors; managing the psychosocial aspects of diabetes (9 items), assessing dissatisfaction and readiness to change (9 items), setting and achieving diabetes goals (10 items). Each question on the diabetes empowerment scale scores between 1 (strongly disagree) to 5 (strongly agree). The total score of the scale, calculated by adding all of the item scores and dividing by 28. High score indicates that the levels of empowerment are high.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Brief COPE</measure>
    <time_frame>Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.</time_frame>
    <description>The Brief COPE assess coping style with stress. Brief COPE include 14 subscale such as self-distraction (items 1 and 19), active coping, (items 2 and 7), denial, (items 3 and 8), substance use, (items 4 and 11), use of emotional support, (items 5 and 15), use of instrumental support, (items 10 and 23), behavioral disengagement, (items 6 and 16),venting, (items 9 and 21), positive reframing, items 12 and 17), planning, (items 14 and 25),humor, (items 18 and 28). each options rate range from 1 (ı'm not doing this at all) to 4 (ı'm doing this a lot), and min-max score range from 2 to 8.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>WHO-five well-being index (WHO-5)</measure>
    <time_frame>Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.</time_frame>
    <description>The WHO-5 well being index was used to psychometrically sound measure of emotional well-being. The answer for each question are given considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The total score changes to ranges from 0 (absence of well-being) to 25 (maximum well-being). The raw score is multiplied by 4 to obtain a percentage score between 0 and 100. When the changes is 10% in raw score, that indicates a significant change.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic questionnaire</measure>
    <time_frame>Before the intervention</time_frame>
    <description>Demographic questionnaire: At first all participants filled a questionnaire covering demographic form, which included the participant's age, gender, education, health habits (smoking, alcohol consumption, participation in sport) and body mass index (BMI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Occupational Therapy</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group received problem solving therapy as 6 modules. Each module was included at least 1 session per week that is nearly 60 minutes, and the amount of weekly sessions was arranged according to the needs of the person.Individuals has an opportunity was provided for identify problems meaningful for themselves and to start their change from the activities they valued by using the COPM.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group had not any intervention we have an education to control group about diabetes and healthy life conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Person centered, occupation based intervention support with problem solving therapy</intervention_name>
    <description>This program that was developed from the occupational therapy perspective which is person centered and occupation based for T2D intervention was designed as 6 modules. The intervention group received person centered, occupation based intervention support with problem solving therapy as 6 modules. The control group had not any intervention, just had a education about effect of diabetes on life.</description>
    <arm_group_label>intervention group</arm_group_label>
    <other_name>self management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of type 2 diabetes&#xD;
&#xD;
          -  Able to read and write turkish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Mental disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ZEYNEP B BAHADIR AGCE, PHD</last_name>
    <role>Study Director</role>
    <affiliation>occupational therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gamze Ekici Çağlar</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zeynep Bahadır Ağce</name>
      <address>
        <city>Istanbul</city>
        <zip>34674</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Weigensberg MJ, Vigen C, Sequeira P, Spruijt-Metz D, Juarez M, Florindez D, Provisor J, Peters A, Pyatak EA. Diabetes Empowerment Council: Integrative Pilot Intervention for Transitioning Young Adults With Type 1 Diabetes. Glob Adv Health Med. 2018 Mar 8;7:2164956118761808. doi: 10.1177/2164956118761808. eCollection 2018.</citation>
    <PMID>29552422</PMID>
  </reference>
  <reference>
    <citation>Hill-Briggs F. Problem solving in diabetes self-management: a model of chronic illness self-management behavior. Ann Behav Med. 2003 Summer;25(3):182-93. doi: 10.1207/S15324796ABM2503_04.</citation>
    <PMID>12763713</PMID>
  </reference>
  <results_reference>
    <citation>Hwang JE, Truax C, Claire M, Caytap AL. Occupational therapy in diabetic care-areas of need perceived by older adults with diabetes. Occup Ther Health Care. 2009;23(3):173-88. doi: 10.1080/07380570902950259.</citation>
    <PMID>23927025</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>February 14, 2020</last_update_submitted>
  <last_update_submitted_qc>February 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uskudar University</investigator_affiliation>
    <investigator_full_name>ZEYNEP BAHADIR AGCE</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Problem Solving</keyword>
  <keyword>Occupational Therapy</keyword>
  <keyword>Healthy Lifestyle</keyword>
  <keyword>Occupational Performance</keyword>
  <keyword>Person-Centered</keyword>
  <keyword>Occupation Based</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03783598
org study id: 569831°
nct id: NCT03783598
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was conducted to investigate the effect of a person-centered, occupation-based
      intervention program supported with problem-solving strategy in individuals with type 2
      diabetes (T2D).

      Method: The study was a randomized controlled trial, that included intervention (n=33) and
      control group (n=34), between the ages of 18 and 65 years.
It was planned as a single-blind, randomized controlled study with 3-month follow-up in
      adults. A total of 67 subjects were randomly allocated to the intervention (n=33) or the
      control group (n=34). This program prepared with consider to meaningful activities for
      individual and overcome to barriers via problem solving. That was designed as 6 modules
      including evaluations, diabetes education and problem-solving therapy. Each module was
      implemented at least 1 session per week, about 60 minutes, and was arranged according to
      individual needs.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The problem solving therapy is an social cognitive therapy approach. And ıt support to solve meaningfull occupational performance problems realted to diabetes by invdividuals and this way, it helps to improve the self-management of diabetes.We used that with person centered perspective and support to person with education which was perspective of person environment occupation model.
primary purpose: Treatment
masking: Single (Participant)
masking description: The study population was 76 individuals whose diagnosis of type 2 diabetes. 9 volunteer individual gave up to participation without for various reasons in the process.That intervention grup (n=33) control group (n=34), between the ages of 18 to 65 years and volunteer individuals.
measure: Canada activity performance measure (COPM)
time frame: Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.
description: COPM, measure self-perceived change in problem on occupational performance and satisfaction over time. The COPM enable individuals to identify and prioritize everyday issues that restrict or impact their performance in everyday living. In the first step, occupational therapist interviews with client determine what the individual has done in his/her routine, what he/she wants to do or can not to do in their self-care, productivity and free time. Secondly the client to rate, on a scale of 1 to 10, the importance of each activity. Then confirming with the client the 5 most important problems and record. The client to rate each problem on performance and satisfaction, then calculate the total scores.
Total scores are calculated by adding together the performance or satisfaction scores for all problems and dividing by the number of problems. At reassessment,the client scores each problem again for performance and satisfaction. Calculate the new scores and the change score.
measure: The diabetes empowerment scale (DES)
time frame: Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.
description: DES measure the psychosocial self-efficacy of people with diabetes. The scale consists of three factors; managing the psychosocial aspects of diabetes (9 items), assessing dissatisfaction and readiness to change (9 items), setting and achieving diabetes goals (10 items). Each question on the diabetes empowerment scale scores between 1 (strongly disagree) to 5 (strongly agree). The total score of the scale, calculated by adding all of the item scores and dividing by 28. High score indicates that the levels of empowerment are high.
measure: The Brief COPE
time frame: Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.
description: The Brief COPE assess coping style with stress. Brief COPE include 14 subscale such as self-distraction (items 1 and 19), active coping, (items 2 and 7), denial, (items 3 and 8), substance use, (items 4 and 11), use of emotional support, (items 5 and 15), use of instrumental support, (items 10 and 23), behavioral disengagement, (items 6 and 16),venting, (items 9 and 21), positive reframing, items 12 and 17), planning, (items 14 and 25),humor, (items 18 and 28). each options rate range from 1 (ı'm not doing this at all) to 4 (ı'm doing this a lot), and min-max score range from 2 to 8.
measure: WHO-five well-being index (WHO-5)
time frame: Intervention and control groups' each participants were analyze before the intervention modules with assessment tools. All assessment tools repeated 6 weeks and 3 months later from the intervention modules.
description: The WHO-5 well being index was used to psychometrically sound measure of emotional well-being. The answer for each question are given considering the last 14 days. Each of the 5 items is scored from 5 (all of the time) to 0 (none of the time). The total score changes to ranges from 0 (absence of well-being) to 25 (maximum well-being). The raw score is multiplied by 4 to obtain a percentage score between 0 and 100. When the changes is 10% in raw score, that indicates a significant change.
measure: Demographic questionnaire
time frame: Before the intervention
description: Demographic questionnaire: At first all participants filled a questionnaire covering demographic form, which included the participant's age, gender, education, health habits (smoking, alcohol consumption, participation in sport) and body mass index (BMI)
arm group label: intervention group
arm group type: Experimental
description: The intervention group received problem solving therapy as 6 modules. Each module was included at least 1 session per week that is nearly 60 minutes, and the amount of weekly sessions was arranged according to the needs of the person.Individuals has an opportunity was provided for identify problems meaningful for themselves and to start their change from the activities they valued by using the COPM.
arm group label: control group
arm group type: No Intervention
description: Control group had not any intervention we have an education to control group about diabetes and healthy life conditions.
intervention type: Behavioral
intervention name: Person centered, occupation based intervention support with problem solving therapy
description: This program that was developed from the occupational therapy perspective which is person centered and occupation based for T2D intervention was designed as 6 modules. The intervention group received person centered, occupation based intervention support with problem solving therapy as 6 modules. The control group had not any intervention, just had a education about effect of diabetes on life.
arm group label: intervention group
other name: self management
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ZEYNEP B BAHADIR AGCE, PHD
role: Study Director
affiliation: occupational therapy
facility: 
facility: 
country: Turkey
citation: Weigensberg MJ, Vigen C, Sequeira P, Spruijt-Metz D, Juarez M, Florindez D, Provisor J, Peters A, Pyatak EA. Diabetes Empowerment Council: Integrative Pilot Intervention for Transitioning Young Adults With Type 1 Diabetes. Glob Adv Health Med. 2018 Mar 8;7:2164956118761808. doi: 10.1177/2164956118761808. eCollection 2018.
PMID: 29552422
citation: Hill-Briggs F. Problem solving in diabetes self-management: a model of chronic illness self-management behavior. Ann Behav Med. 2003 Summer;25(3):182-93. doi: 10.1207/S15324796ABM2503_04.
PMID: 12763713
citation: Hwang JE, Truax C, Claire M, Caytap AL. Occupational therapy in diabetic care-areas of need perceived by older adults with diabetes. Occup Ther Health Care. 2009;23(3):173-88. doi: 10.1080/07380570902950259.
PMID: 23927025
responsible party type: Principal Investigator
investigator affiliation: Uskudar University
investigator full name: ZEYNEP BAHADIR AGCE
investigator title: Assistant professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No