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Virtual Support Intervention for Heart Failure Caregivers

Phase 2

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 9, and 12 months

Awards & highlights

Study Summary

This trial will test whether a virtual support intervention can relieve stress and promote self-care in caregivers of adults with heart failure, and whether it is more efficacious and cost-effective than standard care augmented with health information delivered through the Internet.

Who is the study for?

This trial is for informal caregivers of adults with heart failure who provide at least 8 hours of care weekly and report poor self-care. They must be able to complete the study protocol, speak English, and live within 50 miles of the research office.Check my eligibility

What is being tested?

The ViCCY program is being tested against standard care with health information (HI) alone. Participants are randomly assigned to either receive virtual coaching support sessions in addition to HI or just access to HI over the Internet without additional support.See study design

What are the potential side effects?

Since this intervention involves virtual coaching rather than medication, traditional side effects are not expected. However, participants may experience emotional or psychological responses to discussing caregiving challenges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 9, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 9, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 9, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the Health Self-Care Neglect Scale

Change in the Self-Care Inventory

Secondary outcome measures

Change in Health Status (physical and mental health status)

Change in the Medical Outcomes Study short form 6-dimension (SF-6D)

Change in the Perceived Stress Scale

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment1 Intervention

Caregivers randomized to the intervention ViCCY will receive 10 front-loaded sessions of virtual health coaching by trained registered nurses over 6 months with content based on the theoretical framework (based on the Transactional Model of Stress and Coping) and prior research. Sessions are provided using tablets. Initially, sessions are weekly but the frequency decreases over time as needed. We help caregivers gain the knowledge and skills needed to achieve self-identified health goals through self-care using motivational interviewing. We focus on identifying personal values, solving problems, and transforming goals into action. ViCCY is standardized in a treatment manual. Because stress does not affect all people equally, the intervention is tailored to individual appraisals and the factors most likely to influence demand and perceived burden.

Group II: Health InformationActive Control1 Intervention

The Health Information (HI) group will receive health resource information delivered through the internet.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,002 Previous Clinical Trials

42,880,657 Total Patients Enrolled

42 Trials studying Heart Failure

7,172 Patients Enrolled for Heart Failure

Media Library

ViCCY Clinical Trial Eligibility Overview. Trial Name: NCT03988621 — Phase 2

Heart Failure Research Study Groups: Intervention, Health Information

Heart Failure Clinical Trial 2023: ViCCY Highlights & Side Effects. Trial Name: NCT03988621 — Phase 2

ViCCY 2023 Treatment Timeline for Medical Study. Trial Name: NCT03988621 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How hazardous is ViCCY to human health?

"Our team at Power rated the safety of ViCCY a 2, as clinical data supports its security but no proof exists that it produces results."

Answered by AI

Are any further participants being welcomed into this research trial?

"As confirmed on clinicaltrials.gov, the recruitment period for this medical trial has concluded; it was first posted online in August 2019 and last updated in November 2022. Although candidates are no longer being accepted for this specific research project, there are 697 other studies searching for participants at present."

Answered by AI

What are the essential goals of this trial?

"This trial seeks to ascertain the efficacy of a certain intervention by comparing baseline data with that collected at 6 months. The primary outcome measure is Change in Self-Care Inventory, while secondary outcomes comprise Change in Ways of Coping Questionnaire (a 42-item questionnaire developed by Lazarus and focusing on five coping styles), Difference in Hospital and Provider Events (measuring acute care resource use) and Change in Medical Outcomes Study SF-6D derived from SF-36 for cost efficiency analysis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Self-care of Heart Failure Caregivers

Barbara Riegel, PHD, RN 2019. "Improving Self-care of Heart Failure Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03988621.

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