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/NCT06001541</url>
    </required_header>
    <id_info>
      <org_study_id>IIR 19-137</org_study_id>
      <nct_id>NCT06001541</nct_id>
    </id_info>
    <brief_title>Web-based Program to Improve Self-management Among Veterans-caregiver Dyads</brief_title>
    <acronym>Web-SUCCEED</acronym>
    <official_title>A Web-based Program to Improve Chronic Illness Self-management by Engaging Patients and Informal Caregivers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The majority of Veterans will suffer from at least one chronic illness, often at great&#xD;
        emotional and personal cost. Self-management is critical to improving physical and emotional&#xD;
        outcomes, and many chronically ill Veterans receive self-management assistance from an&#xD;
        informal caregiver, and both Veterans and informal caregivers experience individual and&#xD;
        interpersonal stress as they navigate this journey. Yet, current clinical practices are not&#xD;
        designed to effectively support the needs of both Veterans and their informal caregiver.&#xD;
        Furthermore, self-management practices often require in-person visits, limiting access for&#xD;
        Veterans and informal caregivers who live in rural areas, those with a physical disability,&#xD;
        or those with financial challenges. This project tests a web-based, self-guided, behavioral&#xD;
        intervention that targets the stress coping needs of Veterans with chronic illness and their&#xD;
        informal caregivers. Results from this study could provide an important solution to the&#xD;
        problem of poor self-management, which complicates the lives and prognosis of many Veterans.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: For the 80% of older Americans who have at least one chronic condition, sharing&#xD;
        self-management responsibilities with caregivers (relatives or friends) predicts longevity,&#xD;
        better health, better quality of life, and fewer hospitalizations. Caregivers often support&#xD;
        patients in their self-management efforts. This can bring patients and caregivers closer but&#xD;
        can also generate stress for both that can interfere with self-management. Yet,&#xD;
        self-management programs rarely support the coping needs of patient-caregiver dyads.&#xD;
  &#xD;
        Significance: There are more than 5 million caregivers of Veterans; 75% of older Veterans&#xD;
        receive some caregiver support. Caregivers incur individual financial and emotional costs&#xD;
        even as they provide unpaid care. Having an effective self-management strategy that addresses&#xD;
        the needs of both can improve outcomes and quality of life for millions of Veterans who&#xD;
        suffer from chronic illnesses and their caregivers. This project addresses the priorities&#xD;
        &quot;Long-term care and Caregiving,&quot; &quot;Virtual Care/Telehealth,&quot; and &quot;Access to Care&quot; and is&#xD;
        consistent with the legislative goals of the MISSION Act.&#xD;
  &#xD;
        Innovation and Impact: This highly innovative proposal uses the novel concept that&#xD;
        strengthening the interpersonal relationships between Veterans and caregivers can improve the&#xD;
        self-management of chronic conditions. It challenges current clinical paradigms by addressing&#xD;
        the collective stress coping needs of dyads. It is methodologically innovative because unlike&#xD;
        many behavioral intervention trials, it assesses barriers and facilitators to plan for future&#xD;
        implementation. The focus on technology-enabled tools is timely given how COVID19 has&#xD;
        transformed care delivery. This project takes advantage of the unique capabilities of the VA&#xD;
        health system to explore questions including robust caregiver support and virtual care&#xD;
        programs.&#xD;
  &#xD;
        Specific Aims: With investments from VA HSR&amp;D, the investigators have developed and&#xD;
        successfully pilot tested a new theoretically-derived technology called Web-based Self-care&#xD;
        Using Collaborative Coping EnhancEment in Diseases (web-SUCCEED). We propose to conduct a&#xD;
        randomized clinical trial comparing web-SUCCEED to an enhanced usual care (EUC) control. The&#xD;
        investigators will conduct a formative evaluation guided by the Consolidated Framework of&#xD;
        Implementation Research (CFIR) to accelerate future implementation.&#xD;
  &#xD;
        1. Assess whether web-SUCCEED improves Veteran outcomes of self-management compared to EUC, 4&#xD;
        weeks and 6 months following randomization.&#xD;
  &#xD;
        2a. Assess whether web-SUCCEED improves patient stress and quality of life. 2b. Assess&#xD;
        whether web-SUCCEED improves caregiver stress, quality of life and caregiver burden.&#xD;
  &#xD;
        2c. Examine communication, dyadic coping, mutuality, and relationship quality as mediators of&#xD;
        primary and secondary outcomes (Aims 1, 2a, 2b).&#xD;
  &#xD;
        3. Guided by CFIR, conduct a formative evaluation involving key stakeholder interviews to&#xD;
        understand barriers and facilitators of future implementation.&#xD;
  &#xD;
        Methodology: The investigators will recruit 280 cognitively intact Veterans from VA Palo Alto&#xD;
        Health Care System who are managing at least one common chronic condition, and their&#xD;
        caregivers. Veteran-caregiver dyads will be randomized 1:1 to web-SUCCEED or EUC. Veteran and&#xD;
        caregiver assessments will take place at baseline, then again at 4 weeks and 6 months. The&#xD;
        formative evaluation will be guided by CFIR and involve semi-structured interviews with&#xD;
        clinical staff, providers, and facility leaders in Year 4.&#xD;
  &#xD;
        Next Steps: The formative evaluation will set the investigators up for implementation studies&#xD;
        to evaluate web-SUCCEED in a wider array of clinical settings and facilities. Existing&#xD;
        operational partnerships will facilitate wider clinical implementation and moving research&#xD;
        into practice. The innovative project, strong investigative team and operational partnerships&#xD;
        will ensure a successful study that has the potential to shift clinical paradigms.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">March 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</primary_completion_date>
    <phase>Phase 2</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 investigators propose a randomized clinical trial to evaluate the effectiveness of web-SUCCEED (Web-based Self-management Using Collaborative Coping EnhancEment in Diseases), a theoretically-derived, dyadic, self-management program. Web-SUCCEED is designed to improve self-management by improving dyadic stress coping and strengthening collaboration and communication.21 Web-SUCCEED comprises: 1) a three-module, self-paced behavioral intervention that Veterans and caregivers complete individually (one audio/video module per week) on the web-SUCCEED website; 2) brief, staff-led telephone calls in which dyads participate simultaneously after each module; and 3) peer support via a study-specific discussion board. Dyads learn and practice cognitive behavioral skills to reduce individual and relationship stress; improve positive emotions; improve communication and collaboration; increase pleasant activities; and maintain behavior change.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>the PI will be blinded to randomization and outcomes.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Self-care of Chronic Illness Inventory Change</measure>
      <time_frame>Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)</time_frame>
      <description>The SC-CII is based on the Middle Range Theory of Self-care. [Across three 10-item scales, the SC-CII assesses self-care maintenance (i.e., health-promoting and illness-related behaviors such as treatment adherence), self-care monitoring (i.e., ability to track symptoms and signs of an illness such as shortness of breath), and self-care management (i.e., ability to take action to deal with symptoms such as taking a diuretic to relieve fluid build-up). Coefficient alphas of the 3 subscales are: self-care monitoring (.81), self-care management (.71), and self-care maintenance (.67) in testing with patients with common chronic conditions. Each scale is standardized to a score of 100, and scores of 70 or more on each scale indicate adequate self-management.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PROMIS Profile-29 v2.0</measure>
      <time_frame>Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)</time_frame>
      <description>Common Data Element indexed in the PhenX Toolkit that measures quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiver Reaction Assessment</measure>
      <time_frame>Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)</time_frame>
      <description>Positive and negative caregiver experience.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale</measure>
      <time_frame>Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)</time_frame>
      <description>Self-reported stress measure from PROMIS, 10 items.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Couples Illness Communication Scale</measure>
      <time_frame>Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)</time_frame>
      <description>Self-reported measure of communication, 4 items.</description>
    </other_outcome>
    <other_outcome>
      <measure>Pittsburgh Sleep Quality Index</measure>
      <time_frame>Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)</time_frame>
      <description>Measure of self-reported sleep quality.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">560</enrollment>
    <condition>Chronic Medical Conditions</condition>
    <arm_group>
      <arm_group_label>Web-SUCCEED+Enhanced Usual Care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>web-SUCCEED, usual care, psychoeducational materials and resources for caregivers.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Enhanced Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Usual care, enhanced by psychoeducational materials and resources for caregivers.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Web-SUCCEED</intervention_name>
      <description>web-SUCCEED (Web-based Self-management Using Collaborative Coping EnhancEment in Diseases), a theoretically-derived, dyadic, self-management program.20,21 Web-SUCCEED is designed to improve self-management by improving dyadic stress coping and strengthening collaboration and communication.21 Web-SUCCEED comprises: 1) a three-module, self-paced behavioral intervention that Veterans and caregivers complete individually (one audio/video module per week) on the web-SUCCEED website; 2) brief, staff-led telephone calls in which dyads participate simultaneously after each module; and 3) peer support via a study-specific discussion board. Dyads learn and practice cognitive behavioral skills to reduce individual and relationship stress; improve positive emotions; improve communication and collaboration; increase pleasant activities; and maintain behavior change.</description>
      <arm_group_label>Enhanced Usual Care</arm_group_label>
      <arm_group_label>Web-SUCCEED+Enhanced Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants will be medically eligible if they have been diagnosed with at least one&#xD;
               common chronic condition considered responsive to outpatient management as defined by&#xD;
               being on the AHRQ list of Patient Quality Indicators, which are conditions that are&#xD;
               considered responsive to high quality outpatient care.&#xD;
  &#xD;
            -  The investigators will also include conditions that are disproportionately high among&#xD;
               Veterans (pain, mental health conditions).&#xD;
  &#xD;
            -  Based on the pilot study, the investigators anticipate this to include:&#xD;
  &#xD;
                 -  musculoskeletal pain&#xD;
  &#xD;
                 -  cardiovascular disease&#xD;
  &#xD;
                 -  diabetes&#xD;
  &#xD;
                 -  kidney disease&#xD;
  &#xD;
                 -  depression&#xD;
  &#xD;
            -  Eligible participants will have at least one outpatient visit in the prior 12 months&#xD;
               related to their diagnosis and have a primary caregiver who lives with the Veteran.&#xD;
               Dyads will be excluded if either the Veterans or their caregiver:&#xD;
  &#xD;
                 -  1) have an implantable cardioverter defibrillator&#xD;
  &#xD;
                 -  2) are on hemodialysis&#xD;
  &#xD;
                 -  3) have received an organ transplant or are waitlisted for one&#xD;
  &#xD;
                 -  4) are undergoing chemotherapy or radiation for cancer&#xD;
  &#xD;
                 -  5) have limited life expectancy as determined by the provider or hospice care&#xD;
  &#xD;
                 -  6) have dementia or other major cognitive deficits&#xD;
  &#xD;
                 -  7) have a substance use disorder (SUD), since supporting interpersonal&#xD;
                    relationships in SUDs require specialized training that is outside the scope of&#xD;
                    web-SUCCEED&#xD;
  &#xD;
                 -  8) have a paid caregiver who provides 50% or more support to the Veteran&#xD;
  &#xD;
                 -  9) are actively psychotic or suicidal. Due to content overlap, the investigators&#xD;
                    will exclude Veterans who have participated in the Stanford CDSMP program, and&#xD;
                    caregivers who have participated in the Building Better Caregiver program&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Dyads deemed eligible with these criteria will be further screened by the study staff for&#xD;
          internet use, self-management distress, and interpersonal violence.&#xD;
  &#xD;
            -  a. Internet Use: The investigators will use the question that used in the pilot study,&#xD;
               &quot;How often do you use a computer?&quot; The investigators will exclude dyads where either&#xD;
               Veterans or caregivers answer &quot;less than once a week.&quot;&#xD;
  &#xD;
            -  b. Self-management Distress: The investigators will screen Veterans and caregivers for&#xD;
               self-management distress using the same two-item measure that have been used for the&#xD;
               pilot study of web-SUCCEED:&#xD;
  &#xD;
                 -  1) How overwhelmed do you feel by the demands of living with your [OR Veteran's]&#xD;
                    health condition(s)?&#xD;
  &#xD;
                 -  2) How often do you feel that you are failing in your routine to manage your [OR&#xD;
                    Veteran's] health conditions?&quot; Respondents rate items from 1 (Not a problem) to 6&#xD;
                    (A very serious problem), and scores are added. Dyads will be eligible if both&#xD;
                    individuals score a minimum of 2 and at least one scores &gt;3.&#xD;
  &#xD;
            -  c. Interpersonal Violence: Veterans and caregivers will be separately screened with&#xD;
               the question, &quot;How do you and [Veteran, caregiver] handle stressful conversations or&#xD;
               conflict?&quot; If needed, this will be followed up with: &quot;In the last year, has it gotten&#xD;
               physical or have there been threats of physical force?&quot;. If the answer to the last&#xD;
               question is &quot;yes&quot;, dyads will not be eligible. Dr. Trivedi will assess for immediate&#xD;
               safety, provide local resources, and involve authorities if appropriate. In the&#xD;
               investigators' experience, this is a low likelihood event.&#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>Ranak B Trivedi, PhD MA MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Palo Alto Health Care System, Palo Alto, CA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mary B Walsh, RN</last_name>
      <phone>(412) 260-4289</phone>
      <email>mary.walsh3@va.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>VA Palo Alto Health Care System, Palo Alto, CA</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94304-1207</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Geoffrey W Goodale, BS</last_name>
        <phone>518-626-5626</phone>
        <email>Geoffrey.Goodale@va.gov</email>
      </contact>
      <investigator>
        <last_name>Ranak B Trivedi, PhD MA MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic Disease</keyword>
    <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/NCT06001541
  org study id: IIR 19-137
  nct id: NCT06001541
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The majority of Veterans will suffer from at least one chronic illness, often at great
        emotional and personal cost. Self-management is critical to improving physical and emotional
        outcomes, and many chronically ill Veterans receive self-management assistance from an
        informal caregiver, and both Veterans and informal caregivers experience individual and
        interpersonal stress as they navigate this journey. Yet, current clinical practices are not
        designed to effectively support the needs of both Veterans and their informal caregiver.
        Furthermore, self-management practices often require in-person visits, limiting access for
        Veterans and informal caregivers who live in rural areas, those with a physical disability,
        or those with financial challenges. This project tests a web-based, self-guided, behavioral
        intervention that targets the stress coping needs of Veterans with chronic illness and their
        informal caregivers. Results from this study could provide an important solution to the
        problem of poor self-management, which complicates the lives and prognosis of many Veterans.
  Background: For the 80% of older Americans who have at least one chronic condition, sharing
        self-management responsibilities with caregivers (relatives or friends) predicts longevity,
        better health, better quality of life, and fewer hospitalizations. Caregivers often support
        patients in their self-management efforts. This can bring patients and caregivers closer but
        can also generate stress for both that can interfere with self-management. Yet,
        self-management programs rarely support the coping needs of patient-caregiver dyads.
  
        Significance: There are more than 5 million caregivers of Veterans; 75% of older Veterans
        receive some caregiver support. Caregivers incur individual financial and emotional costs
        even as they provide unpaid care. Having an effective self-management strategy that addresses
        the needs of both can improve outcomes and quality of life for millions of Veterans who
        suffer from chronic illnesses and their caregivers. This project addresses the priorities
        "Long-term care and Caregiving," "Virtual Care/Telehealth," and "Access to Care" and is
        consistent with the legislative goals of the MISSION Act.
  
        Innovation and Impact: This highly innovative proposal uses the novel concept that
        strengthening the interpersonal relationships between Veterans and caregivers can improve the
        self-management of chronic conditions. It challenges current clinical paradigms by addressing
        the collective stress coping needs of dyads. It is methodologically innovative because unlike
        many behavioral intervention trials, it assesses barriers and facilitators to plan for future
        implementation. The focus on technology-enabled tools is timely given how COVID19 has
        transformed care delivery. This project takes advantage of the unique capabilities of the VA
        health system to explore questions including robust caregiver support and virtual care
        programs.
  
        Specific Aims: With investments from VA HSR&D, the investigators have developed and
        successfully pilot tested a new theoretically-derived technology called Web-based Self-care
        Using Collaborative Coping EnhancEment in Diseases (web-SUCCEED). We propose to conduct a
        randomized clinical trial comparing web-SUCCEED to an enhanced usual care (EUC) control. The
        investigators will conduct a formative evaluation guided by the Consolidated Framework of
        Implementation Research (CFIR) to accelerate future implementation.
  
        1. Assess whether web-SUCCEED improves Veteran outcomes of self-management compared to EUC, 4
        weeks and 6 months following randomization.
  
        2a. Assess whether web-SUCCEED improves patient stress and quality of life. 2b. Assess
        whether web-SUCCEED improves caregiver stress, quality of life and caregiver burden.
  
        2c. Examine communication, dyadic coping, mutuality, and relationship quality as mediators of
        primary and secondary outcomes (Aims 1, 2a, 2b).
  
        3. Guided by CFIR, conduct a formative evaluation involving key stakeholder interviews to
        understand barriers and facilitators of future implementation.
  
        Methodology: The investigators will recruit 280 cognitively intact Veterans from VA Palo Alto
        Health Care System who are managing at least one common chronic condition, and their
        caregivers. Veteran-caregiver dyads will be randomized 1:1 to web-SUCCEED or EUC. Veteran and
        caregiver assessments will take place at baseline, then again at 4 weeks and 6 months. The
        formative evaluation will be guided by CFIR and involve semi-structured interviews with
        clinical staff, providers, and facility leaders in Year 4.
  
        Next Steps: The formative evaluation will set the investigators up for implementation studies
        to evaluate web-SUCCEED in a wider array of clinical settings and facilities. Existing
        operational partnerships will facilitate wider clinical implementation and moving research
        into practice. The innovative project, strong investigative team and operational partnerships
        will ensure a successful study that has the potential to shift clinical paradigms.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The investigators propose a randomized clinical trial to evaluate the effectiveness of web-SUCCEED (Web-based Self-management Using Collaborative Coping EnhancEment in Diseases), a theoretically-derived, dyadic, self-management program. Web-SUCCEED is designed to improve self-management by improving dyadic stress coping and strengthening collaboration and communication.21 Web-SUCCEED comprises: 1) a three-module, self-paced behavioral intervention that Veterans and caregivers complete individually (one audio/video module per week) on the web-SUCCEED website; 2) brief, staff-led telephone calls in which dyads participate simultaneously after each module; and 3) peer support via a study-specific discussion board. Dyads learn and practice cognitive behavioral skills to reduce individual and relationship stress; improve positive emotions; improve communication and collaboration; increase pleasant activities; and maintain behavior change.
  primary purpose: Health Services Research
  masking: Single (Investigator)
  masking description: the PI will be blinded to randomization and outcomes.
  measure: Self-care of Chronic Illness Inventory Change
  time frame: Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)
  description: The SC-CII is based on the Middle Range Theory of Self-care. [Across three 10-item scales, the SC-CII assesses self-care maintenance (i.e., health-promoting and illness-related behaviors such as treatment adherence), self-care monitoring (i.e., ability to track symptoms and signs of an illness such as shortness of breath), and self-care management (i.e., ability to take action to deal with symptoms such as taking a diuretic to relieve fluid build-up). Coefficient alphas of the 3 subscales are: self-care monitoring (.81), self-care management (.71), and self-care maintenance (.67) in testing with patients with common chronic conditions. Each scale is standardized to a score of 100, and scores of 70 or more on each scale indicate adequate self-management.
  measure: PROMIS Profile-29 v2.0
  time frame: Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)
  description: Common Data Element indexed in the PhenX Toolkit that measures quality of life.
  measure: Caregiver Reaction Assessment
  time frame: Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)
  description: Positive and negative caregiver experience.
  measure: Perceived Stress Scale
  time frame: Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)
  description: Self-reported stress measure from PROMIS, 10 items.
  measure: Couples Illness Communication Scale
  time frame: Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)
  description: Self-reported measure of communication, 4 items.
  measure: Pittsburgh Sleep Quality Index
  time frame: Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)
  description: Measure of self-reported sleep quality.
  arm group label: Web-SUCCEED+Enhanced Usual Care
  arm group type: Experimental
  description: web-SUCCEED, usual care, psychoeducational materials and resources for caregivers.
  arm group label: Enhanced Usual Care
  arm group type: Active Comparator
  description: Usual care, enhanced by psychoeducational materials and resources for caregivers.
  intervention type: Behavioral
  intervention name: Web-SUCCEED
  description: web-SUCCEED (Web-based Self-management Using Collaborative Coping EnhancEment in Diseases), a theoretically-derived, dyadic, self-management program.20,21 Web-SUCCEED is designed to improve self-management by improving dyadic stress coping and strengthening collaboration and communication.21 Web-SUCCEED comprises: 1) a three-module, self-paced behavioral intervention that Veterans and caregivers complete individually (one audio/video module per week) on the web-SUCCEED website; 2) brief, staff-led telephone calls in which dyads participate simultaneously after each module; and 3) peer support via a study-specific discussion board. Dyads learn and practice cognitive behavioral skills to reduce individual and relationship stress; improve positive emotions; improve communication and collaboration; increase pleasant activities; and maintain behavior change.
  arm group label: Enhanced Usual Care
  arm group label: Web-SUCCEED+Enhanced Usual Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ranak B Trivedi, PhD MA MS
  role: Principal Investigator
  affiliation: VA Palo Alto Health Care System, Palo Alto, CA
  last name: Mary B Walsh, RN
  phone: (412) 260-4289
  email: mary.walsh3@va.gov
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No