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Chronic Medical ConditionsWeb-SUCCEEDNCT06001541

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

A study testing Web-SUCCEED in people with Chronic Medical Conditions, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chronic Medical Conditions
What is being tested?
Web-SUCCEED
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
1 siteUnited States
Study dates
1 May 2024to 30 Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ranak B Trivedi, PhD MA MS contact

(650) 493-5000 ext. 25225

ranak.trivedi@va.gov

Zendrea Marshall, BA MSc contact

(650) 493-5000 ext. 60650

zendrea.marshall@va.gov

United States1 site, 1 recruiting
  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207

    Geoffrey W Goodale, BS, (518) 626-5626, Geoffrey.Goodale@va.gov

    Aman Kumar, (650) 493-5000 ext. 68200, Aman.Kumar@va.gov

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

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). The investigators 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).

  1. Guided by CFIR, conduct a formative evaluation involving key stakeholder interviews to understand barriers and facilitators of future implementation.

Methodology: The investigators will recruit 198 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. The investigators have received approval to now recruit nationally, although the recruitment procedures will be through VAPAHCS.

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.

Being tested
Web-SUCCEED
Keywords
Chronic Disease
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web-SUCCEEDBehavioural

    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.

Study groups in NCT06001541
Study groupRoleWhat they receive
Web-SUCCEED+Enhanced Usual CareExperimentalweb-SUCCEED, usual care, psychoeducational materials and resources for caregivers.
Receives: Behavioral: Web-SUCCEED
Enhanced Usual CareActive comparatorUsual care, enhanced by psychoeducational materials and resources for caregivers.
Receives: Behavioral: Web-SUCCEED

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)
  1. PROMIS Profile-29 v2.0

    Common Data Element indexed in the PhenX Toolkit that measures quality of life.

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

  2. Caregiver Reaction Assessment

    Positive and negative caregiver experience.

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

  3. Perceived Stress Scale

    Self-reported stress measure from PROMIS, 10 items.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start1 May 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06001541
Sponsor's protocol ID
IIR 19-137
Acronym
Web-SUCCEED
Status last verified
Jul 2026
First submitted
14 Aug 2023
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Web-SUCCEED in people with Chronic Medical Conditions, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ranak B Trivedi, PhD MA MS ((650) 493-5000 ext. 25225, ranak.trivedi@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-care of Chronic Illness Inventory Change (time frame: Baseline (pre intervention), 6 week (post intervention), 6 month (follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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