Recruiting

Web-based Program

Sponsor:

VA Office of Research and Development

Code:

NCT06001541

Conditions

Chronic Medical Conditions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Web-SUCCEED

Study Details

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

Study ID

NCT06001541

Start date

May 1, 2024

Status verified date

Jul, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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:

  • 1\) have an implantable cardioverter defibrillator
  • 2\) are on hemodialysis
  • 3\) have received an organ transplant or are waitlisted for one
  • 4\) are undergoing chemotherapy or radiation for cancer
  • 5\) have limited life expectancy as determined by the provider or hospice care
  • 6\) have dementia or other major cognitive deficits
  • 7\) have a substance use disorder (SUD), since supporting interpersonal relationships in SUDs require specialized training that is outside the scope of web-SUCCEED
  • 8\) have a paid caregiver who provides 50% or more support to the Veteran
  • 9\) are actively psychotic or suicidal. Due to content overlap, the investigators will exclude Veterans who have participated in the Stanford CDSMP program, and caregivers who have participated in the Building Better Caregiver program

Exclusion Criteria:

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:

  • 1\) How overwhelmed do you feel by the demands of living with your \[OR Veteran's\] health condition(s)?
  • 2\) 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.

Study Design

Enrollment

396 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Web-SUCCEED+Enhanced Usual Care

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

active comparator: Enhanced Usual Care

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

Interventions

Web-SUCCEED

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. 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 outcome measure

  • Self-care of Chronic Illness Inventory Change [ Time Frame: Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up) ]

Central Contacts and Locations

Central contacts

Ranak B Trivedi, PhD MA MS

(650) 493-5000ranak.trivedi@va.gov

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Principal Investigator:

Ranak B Trivedi, PhD MA MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

  • Chronic Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-20.