RECRUITING

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

Conditions

Chronic Medical Conditions Chronic Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-01

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06001541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Mary B Walsh, RN

CONTACT

(412) 260-4289

mary.walsh3@va.gov

Principal Investigator

Ranak B Trivedi, PhD MA MS

PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Study Locations (Sites)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Ranak B Trivedi, PhD MA MS, PRINCIPAL_INVESTIGATOR, VA Palo Alto Health Care System, Palo Alto, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2024-05-01

Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

Chronic Disease

Additional Relevant MeSH Terms

Chronic Medical Conditions