Web-based program to help Veterans and their caregivers manage chronic conditions

A Web-based Program to Improve Chronic Illness Self-management by Engaging Patients and Informal Caregivers

This study tests a web-based program to help Veterans with chronic illnesses and their caregivers manage stress and improve their health together.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 560 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: VA Office of Research and Development (fed)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Palo Alto, California)
• Trial ID: NCT06001541 on ClinicalTrials.gov

What this trial studies

This project tests a web-based, self-guided behavioral intervention designed to improve self-management among Veterans with chronic illnesses and their informal caregivers. The program addresses the stress coping needs of both parties, recognizing that effective self-management often requires support from caregivers. By providing a virtual solution, it aims to enhance access for Veterans and caregivers who may face barriers such as living in rural areas or having physical disabilities. The intervention focuses on strengthening the interpersonal relationships between Veterans and caregivers to improve health outcomes and quality of life.

Who should consider this trial

Good fit: Ideal candidates include Veterans diagnosed with at least one chronic condition and who have a primary caregiver living with them.

Not a fit: Patients who have implantable cardioverter defibrillators, are on hemodialysis, or have received an organ transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly enhance the quality of life and health outcomes for Veterans with chronic conditions and their caregivers.

How similar studies have performed: Other studies have shown success with similar web-based interventions aimed at improving self-management in chronic conditions, indicating a promising approach.

Eligibility criteria

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.

Where this trial is running

Palo Alto, California

• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto, California, United States (RECRUITING)

Study contacts

• Principal investigator: Ranak B Trivedi, PhD MA MS — VA Palo Alto Health Care System, Palo Alto, CA
• Study coordinator: Mary B Walsh, RN

Conditions: Chronic Medical Conditions, Chronic Disease