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/NCT05990114</url>
    </required_header>
    <id_info>
      <org_study_id>department of gerontology</org_study_id>
      <nct_id>NCT05990114</nct_id>
    </id_info>
    <brief_title>Evaluation of the Structured Caregiver Support Program (SCSP) in Terms of Various Parameters</brief_title>
    <acronym>SCSP</acronym>
    <official_title>Evaluation of the Effect of Structured Caregiver Support Program on the Levels of Care Burden, Psychological Well-Being and Psychological Resilience of Informal Caregivers of Alzheimer's Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Akdeniz University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Akdeniz University</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 aim of this clinical study is to examine the effect of an intervention program developed&#xD;
        for informal caregivers of Alzheimer's patients on caregivers' burden of care, psychological&#xD;
        well-being and psychological resilience.The main questions it aims to answer are:&#xD;
  &#xD;
          1. What is the effect of the Structured Caregiver Support Program (SCSP) on caregivers&#xD;
             burden?&#xD;
  &#xD;
          2. What is the effect of the SCSP on psychological well-being?&#xD;
  &#xD;
          3. What is the effect of the SCSP on psychological resilience?&#xD;
  &#xD;
        Participants (intervention group) will attend at least 6 sessions of an 8-session SCSP.&#xD;
  &#xD;
        Researchers will compare with the control group to see if the training provided is effective.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        People around the world are now living longer. The number of elderly people in need of care&#xD;
        is increasing, especially among the population aged 80 and over, which is defined as advanced&#xD;
        old age. Elderly care in Turkey is largely informal by family members. A significant&#xD;
        proportion of caregivers suffer from the burden of care. Alzheimer's disease (AD) is a&#xD;
        neurodegenerative and progressive disease that causes need for care in advanced age.&#xD;
        Caregivers of people with AD report more stress, burden and depression than caregivers of&#xD;
        other patients, especially in cases where neuropsychiatric symptoms are evident.&#xD;
        Psychological well-being and psychological resilience of caregivers are also negatively&#xD;
        affected by the care process. Therefore, caregivers need psychological and social support.&#xD;
        The aim of this study is to evaluate the effect of the Structured Caregiver Support Program,&#xD;
        which will be created to support caregivers psychologically and socially, on the caregiving&#xD;
        burden, psychological well-being and psychological resilience levels of informal caregivers&#xD;
        caring for Alzheimer's patients.&#xD;
  &#xD;
        Mixed design consisting of quantitative and qualitative research methods will be used in the&#xD;
        research.The quantitative dimension of the research will be carried out as a randomized&#xD;
        controlled experimental study and a pre-test and post-test order will be used.In this&#xD;
        context, an intervention program was created to examine the effect of the Structured&#xD;
        Caregiver Support Program on caregivers' burden of caregiving, psychological well-being and&#xD;
        psychological resilience.There will be two different groups in the study, namely the&#xD;
        intervention group and the control group.Participants who volunteer to participate in the&#xD;
        study will be randomly assigned to the intervention and control groups.SCSP intervention will&#xD;
        be applied to the intervention group and no intervention will be applied to the control&#xD;
        group.Pre-test and post-test will be applied to both the intervention and control groups&#xD;
        before and after the intervention program.&#xD;
  &#xD;
        The universe of the research consists of caregivers of patients with Alzheimer's diagnosis&#xD;
        followed up in the Alzheimer's Social Life Center of a municipality in Ankara between&#xD;
        September and December 2023.The sample of the study consists of caregivers who meet the&#xD;
        criteria for inclusion in the sample of patients with Alzheimer's diagnosis followed in the&#xD;
        Alzheimer's Social Life Center of a municipality in Ankara between September and December&#xD;
        2023.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">November 2023</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>Randomized Controlled Trial</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Zarit Burden Interview</measure>
      <time_frame>8 week</time_frame>
      <description>This scale, which was developed by Zarit, Reever and Bach-Peterson in 1980, is used to measure the stress of caregivers.A minimum of 0 and a maximum of 88 points can be obtained from the scale. A high score on the scale indicates a high level of distress.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Psychological Well-Being Scale</measure>
      <time_frame>8 week</time_frame>
      <description>The 8-item Psychological Well-Being Scale, developed by Diener et al. in 2009, includes important elements of human functioning such as positive relationships, feelings of efficacy, and having a meaningful and purposeful life, and evaluates the individual's psychological well-being.A minimum of 8 and a maximum of 56 points can be obtained from the scale. A high score indicates that the person has many psychological resources and strengths.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Brief Resilience Scale</measure>
      <time_frame>8 week</time_frame>
      <description>It is a 6-item self-report scale developed by Smith et al. in 2008. After the reverse coded items in the scale were translated, high scores indicate high psychological resilience.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Alzheimer Disease</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The structured caregiver support program is a psychosocial training program developed to improve caregivers' burden of care, psychological well-being and resilience.This training program will be applied to the intervention group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No intervention will be applied to the control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>The structured caregiver support program</intervention_name>
      <description>It consists of 8 sessions in total. It is planned as once a week and 45 minutes.</description>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Providing informal care to an individual with Alzheimer's disease&#xD;
  &#xD;
            -  Being a primary caregiver&#xD;
  &#xD;
            -  The caregiver is 18 years or older&#xD;
  &#xD;
            -  Residency of the caregiver in the province of Ankara&#xD;
  &#xD;
            -  Willingness and volunteering to participate in the research&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Hearing and understanding difficulties&#xD;
  &#xD;
            -  Having a psychiatric disorder&#xD;
  &#xD;
            -  Receiving any therapy services&#xD;
  &#xD;
            -  Caregivers who did not attend two or more of the eight interviews were excluded.&#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>Hande Kirisik, Lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ankara University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Akdeniz University</name>
        <address>
          <city>Antalya</city>
          <state>Konyaaltı</state>
          <zip>07070</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Akdeniz University</investigator_affiliation>
      <investigator_full_name>Hande Kirisik</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>psychosocial intervention</keyword>
    <keyword>Alzheimer's disease</keyword>
    <keyword>caregivers</keyword>
    <keyword>care burden</keyword>
    <keyword>psychological well-being</keyword>
    <keyword>psychological resilience</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alzheimer Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05990114
  org study id: department of gerontology
  nct id: NCT05990114
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this clinical study is to examine the effect of an intervention program developed
        for informal caregivers of Alzheimer's patients on caregivers' burden of care, psychological
        well-being and psychological resilience.The main questions it aims to answer are:
  
          1. What is the effect of the Structured Caregiver Support Program (SCSP) on caregivers
             burden?
  
          2. What is the effect of the SCSP on psychological well-being?
  
          3. What is the effect of the SCSP on psychological resilience?
  
        Participants (intervention group) will attend at least 6 sessions of an 8-session SCSP.
  
        Researchers will compare with the control group to see if the training provided is effective.
  People around the world are now living longer. The number of elderly people in need of care
        is increasing, especially among the population aged 80 and over, which is defined as advanced
        old age. Elderly care in Turkey is largely informal by family members. A significant
        proportion of caregivers suffer from the burden of care. Alzheimer's disease (AD) is a
        neurodegenerative and progressive disease that causes need for care in advanced age.
        Caregivers of people with AD report more stress, burden and depression than caregivers of
        other patients, especially in cases where neuropsychiatric symptoms are evident.
        Psychological well-being and psychological resilience of caregivers are also negatively
        affected by the care process. Therefore, caregivers need psychological and social support.
        The aim of this study is to evaluate the effect of the Structured Caregiver Support Program,
        which will be created to support caregivers psychologically and socially, on the caregiving
        burden, psychological well-being and psychological resilience levels of informal caregivers
        caring for Alzheimer's patients.
  
        Mixed design consisting of quantitative and qualitative research methods will be used in the
        research.The quantitative dimension of the research will be carried out as a randomized
        controlled experimental study and a pre-test and post-test order will be used.In this
        context, an intervention program was created to examine the effect of the Structured
        Caregiver Support Program on caregivers' burden of caregiving, psychological well-being and
        psychological resilience.There will be two different groups in the study, namely the
        intervention group and the control group.Participants who volunteer to participate in the
        study will be randomly assigned to the intervention and control groups.SCSP intervention will
        be applied to the intervention group and no intervention will be applied to the control
        group.Pre-test and post-test will be applied to both the intervention and control groups
        before and after the intervention program.
  
        The universe of the research consists of caregivers of patients with Alzheimer's diagnosis
        followed up in the Alzheimer's Social Life Center of a municipality in Ankara between
        September and December 2023.The sample of the study consists of caregivers who meet the
        criteria for inclusion in the sample of patients with Alzheimer's diagnosis followed in the
        Alzheimer's Social Life Center of a municipality in Ankara between September and December
        2023.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Controlled Trial
  primary purpose: Health Services Research
  masking: Double (Participant, Care Provider)
  measure: Zarit Burden Interview
  time frame: 8 week
  description: This scale, which was developed by Zarit, Reever and Bach-Peterson in 1980, is used to measure the stress of caregivers.A minimum of 0 and a maximum of 88 points can be obtained from the scale. A high score on the scale indicates a high level of distress.
  measure: Psychological Well-Being Scale
  time frame: 8 week
  description: The 8-item Psychological Well-Being Scale, developed by Diener et al. in 2009, includes important elements of human functioning such as positive relationships, feelings of efficacy, and having a meaningful and purposeful life, and evaluates the individual's psychological well-being.A minimum of 8 and a maximum of 56 points can be obtained from the scale. A high score indicates that the person has many psychological resources and strengths.
  measure: Brief Resilience Scale
  time frame: 8 week
  description: It is a 6-item self-report scale developed by Smith et al. in 2008. After the reverse coded items in the scale were translated, high scores indicate high psychological resilience.
  arm group label: intervention group
  arm group type: Experimental
  description: The structured caregiver support program is a psychosocial training program developed to improve caregivers' burden of care, psychological well-being and resilience.This training program will be applied to the intervention group.
  arm group label: control group
  arm group type: No Intervention
  description: No intervention will be applied to the control group.
  intervention type: Other
  intervention name: The structured caregiver support program
  description: It consists of 8 sessions in total. It is planned as once a week and 45 minutes.
  arm group label: intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hande Kirisik, Lecturer
  role: Principal Investigator
  affiliation: Ankara University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Akdeniz University
  investigator full name: Hande Kirisik
  investigator title: Lecturer
  mesh term: Alzheimer Disease
  sharing ipd: No