xml: <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/NCT06042634</url>
    </required_header>
    <id_info>
      <org_study_id>online psychoeducation</org_study_id>
      <nct_id>NCT06042634</nct_id>
    </id_info>
    <brief_title>A Feasibility Study of Online Psychoeducation for Family Caregivers of People With Dementia</brief_title>
    <official_title>An Evidence-based Online Psychoeducation for Family Caregivers of People With Dementia: A Feasibility Study</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>
        The goal of this clinical trial is to evaluate the feasibility and acceptability of online&#xD;
        psychoeducation in the family caregivers of people with dementia living in the community. The&#xD;
        main objectives it aims to answer are:&#xD;
  &#xD;
          1. Is online psychoeducation feasible and acceptable to family caregivers of people with&#xD;
             dementia?&#xD;
  &#xD;
          2. What is the preliminary effect of online psychoeducation on caregiving self-efficacy in&#xD;
             family caregivers of people with dementia?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study employed a quasi-experimental pretest-posttest design to compare online&#xD;
        psychoeducation with conventional face-to-face psychoeducation. This study also included a&#xD;
        qualitative study as process evaluation to explore the participants' experiences with the&#xD;
        online psychoeducation.&#xD;
  &#xD;
        Caregivers of people with dementia were recruited from two sources: elderly community centers&#xD;
        and Facebook. Printed flyers were physically displayed in the elderly community centers and&#xD;
        advertisements were posted on Facebook. Interested participants approached the principal&#xD;
        investigator through telephone and were screened for eligibility. Informed consent was&#xD;
        collected physically at the elderly community centers or via Google Forms.&#xD;
  &#xD;
        The feasibility study required 30 participants per arm to test the intervention before a&#xD;
        future definitive trial. Therefore, with two groups in this study, the total sample size was&#xD;
        set at 60.&#xD;
  &#xD;
        Participants recruited from the elderly community centers were allocated to the face-to-face&#xD;
        group, whilst participants recruited from Facebook were allocated to the online group. The&#xD;
        rationale for having a non-randomized design was to prevent potential contamination occurring&#xD;
        due to information sharing among the participants. Participants were informed of the group&#xD;
        allocation at the time of recruitment.&#xD;
  &#xD;
        The sociodemographic data and outcomes were collected by an research assistant. All&#xD;
        participants were also asked to complete the satisfaction questionnaire at T1. Questions for&#xD;
        the satisfaction questionnaire and caregiving self-efficacy questionnaire were read out to&#xD;
        participants.&#xD;
  &#xD;
        Quantitative data were analyzed using the IBM SPSS Statistics version 26.0. Descriptive&#xD;
        statistics were used to summarize the demographic data and the feasibility outcomes including&#xD;
        recruitment rate, attrition rates, completion rate of intervention, participants'&#xD;
        satisfaction score and completion rate of instrument. Chi-square test for the categorical&#xD;
        variables and independent T-test for the continuous variables were used to examine the&#xD;
        homogeneity of the participants in the two intervention groups. Analysis of Covariance was&#xD;
        performed to examine between group differences in Revised Scale of Caregiving Self-Efficacy&#xD;
        (RSCSE) score, with the respective pretest score as covariate. Paired T-test was also&#xD;
        performed to examine within group differences in RSCSE score. Effect size was measured by&#xD;
        dividing the mean difference within the group by the pooled standard deviation and reported&#xD;
        as Cohen's d value. The cut-off points of small, medium and large effect size were 0.2, 0.5&#xD;
        and 0.8 respectively. All analysis was considered significant at p≤ 0.05 (2-tailed).&#xD;
  &#xD;
        The audio-recorded interviews were transcribed verbatim for qualitative content analysis. The&#xD;
        transcripts were managed with the support of Nvivo 14 for systematic organization of the&#xD;
        data. The authors read the transcripts multiple times to get familiar with the data. They&#xD;
        then coded the data and developed initial themes independently. Critical discussion and&#xD;
        revision on the themes and subthemes were carried out until a consensus was reached. The main&#xD;
        themes and subthemes were refined and named collaboratively. Illustrative quotes were&#xD;
        selected through critical discussion between authors. The first author translated the quotes&#xD;
        to English while the other authors helped with verification and proofreading.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 15, 2022</start_date>
    <completion_date type="Actual">January 31, 2023</completion_date>
    <primary_completion_date type="Actual">January 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Parallel arm of 1:1 ratio</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Outcomes assessor was blinded to group allocation of participants</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Sociodemographic background</measure>
      <time_frame>Baseline</time_frame>
      <description>Caregiver: Age, gender, marital status, relationship with care recipient, caregiving experience, education level, level of confidence in caregiving; Care recipient: age, gender, duration of dementia since diagnose, level of assistance required in activity daily living, stage of dementia</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The proportion of eligible subjects and consented to join the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Attrition rate</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The proportion of consented subjects who dropped out of the study. The reasons for attrition such as refusal were recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Completion rate</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The proportion of participants who attended at least 4 out of 6 sessions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Class attendance</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The proportion of participants who attended the class in each session</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Completion rate of study instrument</measure>
      <time_frame>Through study completion, an average of 6 months</time_frame>
      <description>The proportion of participants who completed the study instrument</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Satisfaction of intervention</measure>
      <time_frame>On completion of intervention at 6 weeks</time_frame>
      <description>Participants rated on the content, format and appropriateness of intervention on a 5-point Likert scale. The higher total score represented greater satisfaction with the intervention</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Experience of online psychoeducation</measure>
      <time_frame>On completion of intervention at 6 weeks</time_frame>
      <description>Individual semi-structured interviews were conducted to explore the experience of online psychoeducation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Caregiving self-efficacy</measure>
      <time_frame>Baseline and on completion of intervention at 6 weeks</time_frame>
      <description>Participants completed the Revised Scale of Caregiving Self-efficacy. There are 15 questions in total and participant rated on a scale of 0-100 on each question. The mean score of 15 questions will be presented and the higher the score represented the higher level of caregiving self-efficacy.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Dementia</condition>
    <arm_group>
      <arm_group_label>Online psychoeducation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The online psychoeducation was presented virtually via Zoom videoconferencing for synchronous group meeting. It has two core components: didactic teaching and active participation. The didactic teaching provided information support about dementia caregiving which was delivered via Powerpoint presentations. The programme allowed: (1) hands-on skill training opportunities to rehearse caregiving skills through simulation and written assignments; (2) sharing of caregiving experiences and learning vicariously from other participants through group discussion; (3) reflection on own caregiving approach; and (4) addressing negative emotions through practicing relaxation technique. Participants went through six-weekly psychoeducation sessions in a small group of five to eight. Each psychoeducation session consisted of didactic teaching and active participation which lasted for 120 minutes. Participants went through discussion, simulation and was given home assignment weekly.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Face-to-face psychoeducation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Face-to-face psychoeducation had the same content and flow of presentation as online psychoeducation. The only difference was the mode of delivery which was presented physically in the community center.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Online psychoeducation</intervention_name>
      <description>Online psychoeducation aimed to enhance the knowledge and skill of family caregivers of people with dementia, who could not physically attend in-person class. Knowledge covering dementia caregiving including disease nature, communication skill, stress and coping, daily care, management of behavioral and psychological symptoms of dementia, and future planning. The intervention provided opportunities to practice through simulation and weekly home assignment. There was a total of 6 sessions and provided weekly. Each session lasted for 2 hours. Participants had discussion with peers and coached by a facilitator. Online psychoeducation wad delivered via Zoom videoconferencing.</description>
      <arm_group_label>Online psychoeducation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Face-to-face psychoeducation</intervention_name>
      <description>Face-to-face psychoeducation has the same content and flow of presentation as online psychoeducation.</description>
      <arm_group_label>Face-to-face psychoeducation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  cognitively competent (i.e. Mini Mental State Examination ≥23)&#xD;
  &#xD;
            -  taking care of a family member diagnosed with dementia of mild to moderate stage and&#xD;
               required assistance in physical activities of daily living (ADL) (i.e. score ≥2 on the&#xD;
               ADL scale&#xD;
  &#xD;
            -  at least 5 hours of caregiving per week in the past month&#xD;
  &#xD;
            -  had low caregiving self-efficacy (i.e. score ≤3 on the Caregiving Competence Scale&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  currently participating in any other psychosocial interventional program&#xD;
  &#xD;
            -  had psychiatric illnesses and had active treatment&#xD;
  &#xD;
            -  did not had access to the Internet on any type of electronic device such as smart&#xD;
               phone or laptop.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hoi Man Chan, master</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nethersole School of Nursing, Chinese University of Hong Kong</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Nethersole School of Nursing, Chinese University of Hong Kong</name>
        <address>
          <city>Hong Kong</city>
          <country>Hong Kong</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Hong Kong</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 16, 2023</last_update_submitted>
    <last_update_submitted_qc>September 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Chan Hoi Man Jackie</investigator_full_name>
      <investigator_title>Student of Doctoral in Nursing</investigator_title>
    </responsible_party>
    <keyword>family caregivers</keyword>
    <keyword>online</keyword>
    <keyword>psychoeducation</keyword>
    <keyword>self-efficacy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Upon request to the principal investigator, Jackie Chan Hoi Man via email: 1010155350@link.cuhk.edu.hk</ipd_description>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>2 years after completion of study and for 5 years</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042634
  org study id: online psychoeducation
  nct id: NCT06042634
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the feasibility and acceptability of online
        psychoeducation in the family caregivers of people with dementia living in the community. The
        main objectives it aims to answer are:
  
          1. Is online psychoeducation feasible and acceptable to family caregivers of people with
             dementia?
  
          2. What is the preliminary effect of online psychoeducation on caregiving self-efficacy in
             family caregivers of people with dementia?
  This study employed a quasi-experimental pretest-posttest design to compare online
        psychoeducation with conventional face-to-face psychoeducation. This study also included a
        qualitative study as process evaluation to explore the participants' experiences with the
        online psychoeducation.
  
        Caregivers of people with dementia were recruited from two sources: elderly community centers
        and Facebook. Printed flyers were physically displayed in the elderly community centers and
        advertisements were posted on Facebook. Interested participants approached the principal
        investigator through telephone and were screened for eligibility. Informed consent was
        collected physically at the elderly community centers or via Google Forms.
  
        The feasibility study required 30 participants per arm to test the intervention before a
        future definitive trial. Therefore, with two groups in this study, the total sample size was
        set at 60.
  
        Participants recruited from the elderly community centers were allocated to the face-to-face
        group, whilst participants recruited from Facebook were allocated to the online group. The
        rationale for having a non-randomized design was to prevent potential contamination occurring
        due to information sharing among the participants. Participants were informed of the group
        allocation at the time of recruitment.
  
        The sociodemographic data and outcomes were collected by an research assistant. All
        participants were also asked to complete the satisfaction questionnaire at T1. Questions for
        the satisfaction questionnaire and caregiving self-efficacy questionnaire were read out to
        participants.
  
        Quantitative data were analyzed using the IBM SPSS Statistics version 26.0. Descriptive
        statistics were used to summarize the demographic data and the feasibility outcomes including
        recruitment rate, attrition rates, completion rate of intervention, participants'
        satisfaction score and completion rate of instrument. Chi-square test for the categorical
        variables and independent T-test for the continuous variables were used to examine the
        homogeneity of the participants in the two intervention groups. Analysis of Covariance was
        performed to examine between group differences in Revised Scale of Caregiving Self-Efficacy
        (RSCSE) score, with the respective pretest score as covariate. Paired T-test was also
        performed to examine within group differences in RSCSE score. Effect size was measured by
        dividing the mean difference within the group by the pooled standard deviation and reported
        as Cohen's d value. The cut-off points of small, medium and large effect size were 0.2, 0.5
        and 0.8 respectively. All analysis was considered significant at p≤ 0.05 (2-tailed).
  
        The audio-recorded interviews were transcribed verbatim for qualitative content analysis. The
        transcripts were managed with the support of Nvivo 14 for systematic organization of the
        data. The authors read the transcripts multiple times to get familiar with the data. They
        then coded the data and developed initial themes independently. Critical discussion and
        revision on the themes and subthemes were carried out until a consensus was reached. The main
        themes and subthemes were refined and named collaboratively. Illustrative quotes were
        selected through critical discussion between authors. The first author translated the quotes
        to English while the other authors helped with verification and proofreading.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel arm of 1:1 ratio
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  masking description: Outcomes assessor was blinded to group allocation of participants
  measure: Sociodemographic background
  time frame: Baseline
  description: Caregiver: Age, gender, marital status, relationship with care recipient, caregiving experience, education level, level of confidence in caregiving; Care recipient: age, gender, duration of dementia since diagnose, level of assistance required in activity daily living, stage of dementia
  measure: Recruitment rate
  time frame: Through study completion, an average of 6 months
  description: The proportion of eligible subjects and consented to join the study.
  measure: Attrition rate
  time frame: Through study completion, an average of 6 months
  description: The proportion of consented subjects who dropped out of the study. The reasons for attrition such as refusal were recorded.
  measure: Completion rate
  time frame: Through study completion, an average of 6 months
  description: The proportion of participants who attended at least 4 out of 6 sessions.
  measure: Class attendance
  time frame: Through study completion, an average of 6 months
  description: The proportion of participants who attended the class in each session
  measure: Completion rate of study instrument
  time frame: Through study completion, an average of 6 months
  description: The proportion of participants who completed the study instrument
  measure: Satisfaction of intervention
  time frame: On completion of intervention at 6 weeks
  description: Participants rated on the content, format and appropriateness of intervention on a 5-point Likert scale. The higher total score represented greater satisfaction with the intervention
  measure: Experience of online psychoeducation
  time frame: On completion of intervention at 6 weeks
  description: Individual semi-structured interviews were conducted to explore the experience of online psychoeducation.
  measure: Caregiving self-efficacy
  time frame: Baseline and on completion of intervention at 6 weeks
  description: Participants completed the Revised Scale of Caregiving Self-efficacy. There are 15 questions in total and participant rated on a scale of 0-100 on each question. The mean score of 15 questions will be presented and the higher the score represented the higher level of caregiving self-efficacy.
  arm group label: Online psychoeducation
  arm group type: Experimental
  description: The online psychoeducation was presented virtually via Zoom videoconferencing for synchronous group meeting. It has two core components: didactic teaching and active participation. The didactic teaching provided information support about dementia caregiving which was delivered via Powerpoint presentations. The programme allowed: (1) hands-on skill training opportunities to rehearse caregiving skills through simulation and written assignments; (2) sharing of caregiving experiences and learning vicariously from other participants through group discussion; (3) reflection on own caregiving approach; and (4) addressing negative emotions through practicing relaxation technique. Participants went through six-weekly psychoeducation sessions in a small group of five to eight. Each psychoeducation session consisted of didactic teaching and active participation which lasted for 120 minutes. Participants went through discussion, simulation and was given home assignment weekly.
  arm group label: Face-to-face psychoeducation
  arm group type: Active Comparator
  description: Face-to-face psychoeducation had the same content and flow of presentation as online psychoeducation. The only difference was the mode of delivery which was presented physically in the community center.
  intervention type: Behavioral
  intervention name: Online psychoeducation
  description: Online psychoeducation aimed to enhance the knowledge and skill of family caregivers of people with dementia, who could not physically attend in-person class. Knowledge covering dementia caregiving including disease nature, communication skill, stress and coping, daily care, management of behavioral and psychological symptoms of dementia, and future planning. The intervention provided opportunities to practice through simulation and weekly home assignment. There was a total of 6 sessions and provided weekly. Each session lasted for 2 hours. Participants had discussion with peers and coached by a facilitator. Online psychoeducation wad delivered via Zoom videoconferencing.
  arm group label: Online psychoeducation
  intervention type: Behavioral
  intervention name: Face-to-face psychoeducation
  description: Face-to-face psychoeducation has the same content and flow of presentation as online psychoeducation.
  arm group label: Face-to-face psychoeducation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hoi Man Chan, master
  role: Principal Investigator
  affiliation: Nethersole School of Nursing, Chinese University of Hong Kong
  facility: 
  country: Hong Kong
  responsible party type: Principal Investigator
  investigator affiliation: Chinese University of Hong Kong
  investigator full name: Chan Hoi Man Jackie
  investigator title: Student of Doctoral in Nursing
  mesh term: Dementia
  sharing ipd: Yes
  ipd description: Upon request to the principal investigator, Jackie Chan Hoi Man via email: 1010155350@link.cuhk.edu.hk
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: 2 years after completion of study and for 5 years