Web-based Program to Improve Self-management Among Veterans-caregiver Dyads

NCT06001541 | Recruiting

• 1 other identifier: IIR 19-137
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Medical Conditions

Keywords

Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Self-care of Chronic Illness Inventory Change

  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.

  Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)

Secondary Outcomes (3)

• PROMIS Profile-29 v2.0

  Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)

• Caregiver Reaction Assessment

  Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)

• Perceived Stress Scale

  Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)

Other Outcomes (2)

• Couples Illness Communication Scale

  Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)

• Pittsburgh Sleep Quality Index

  Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)

Study Arms (2)

Web-SUCCEED+Enhanced Usual Care

EXPERIMENTAL

web-SUCCEED, usual care, psychoeducational materials and resources for caregivers.

Behavioral: Web-SUCCEED

Enhanced Usual Care

ACTIVE COMPARATOR

Usual care, enhanced by psychoeducational materials and resources for caregivers.

Behavioral: Web-SUCCEED

Interventions

Web-SUCCEED BEHAVIORAL

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.

Enhanced Usual Care; Web-SUCCEED+Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be medically eligible if they have been diagnosed with at least one common chronic condition considered responsive to outpatient management as defined by being on the AHRQ list of Patient Quality Indicators, which are conditions that are considered responsive to high quality outpatient care.
• The investigators will also include conditions that are disproportionately high among Veterans (pain, mental health conditions).
• Based on the pilot study, the investigators anticipate this to include:
• musculoskeletal pain
• cardiovascular disease
• diabetes
• kidney disease
• depression
• Eligible participants will have at least one outpatient visit in the prior 12 months related to their diagnosis and have a primary caregiver who lives with the Veteran. Dyads will be excluded if either the Veterans or their caregiver:
• \) have an implantable cardioverter defibrillator
• \) are on hemodialysis
• \) have received an organ transplant or are waitlisted for one
• \) are undergoing chemotherapy or radiation for cancer
• \) have limited life expectancy as determined by the provider or hospice care
• \) have dementia or other major cognitive deficits

You may not qualify if:

• Dyads deemed eligible with these criteria will be further screened by the study staff for internet use, self-management distress, and interpersonal violence.
• a. Internet Use: The investigators will use the question that used in the pilot study, "How often do you use a computer?" The investigators will exclude dyads where either Veterans or caregivers answer "less than once a week."
• b. Self-management Distress: The investigators will screen Veterans and caregivers for self-management distress using the same two-item measure that have been used for the pilot study of web-SUCCEED:
• \) How overwhelmed do you feel by the demands of living with your \[OR Veteran's\] health condition(s)?
• \) How often do you feel that you are failing in your routine to manage your \[OR Veteran's\] health conditions?" Respondents rate items from 1 (Not a problem) to 6 (A very serious problem), and scores are added. Dyads will be eligible if both individuals score a minimum of 2 and at least one scores \>3.
• c. Interpersonal Violence: Veterans and caregivers will be separately screened with the question, "How do you and \[Veteran, caregiver\] handle stressful conversations or conflict?" If needed, this will be followed up with: "In the last year, has it gotten physical or have there been threats of physical force?". If the answer to the last question is "yes", dyads will not be eligible. Dr. Trivedi will assess for immediate safety, provide local resources, and involve authorities if appropriate. In the investigators' experience, this is a low likelihood event.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ranak B Trivedi, PhD MA MS

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary B Walsh, RN

CONTACT

(412) 260-4289; mary.walsh3@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: the PI will be blinded to randomization and outcomes.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)