Taking Care of Us for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Heart Failure
Taking Care of Us - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new way to help heart failure patients and their caregivers, to see if it's more effective than usual education and counseling.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Heart Failure

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: 5 months baseline

5 months after baseline
Change in care strain scores in spouses in the TCU vs SUPPORT condition as assessed by the 16-item Multidimensional Caregiver Strain Index.
Change in collaboration scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Collaboration in Chronic Illness measure.
Change in communication scores in couples in the TCU vs SUPPORT condition as assessed by the 11-item Dyadic Coping Scale.
Change in confidence scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Stanford Confidence to Manage Chronic Illness measure.
Change in depressive symptom scores in couples in the TCU vs SUPPORT condition as assessed by the 20-item Center for Epidemiological Studies Depression CESD measure.
Change in difference in dyspnea scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item Heart Failure Somatic Perception Scale.
Change in difference in pain interference scores in couples in the TCU vs SUPPORT condition as assessed by the 6-item PROMIS Pain Interference measure.
Change in healthcare utilization scores in couples in the TCU vs SUPPORT condition as assessed by the 5-item Stanford Patient Education Research Center PERC Healthcare Utilization measure.
Change in heart failure related quality of life scores in persons with heart failure in the TCU vs SUPPORT condition as assessed by the 12-item Kansas City Cardiomyopathy Questionnaire.
Change in quality of life scores in couples in the TCU vs SUPPORT condition assessed by the 10-item PROMIS Global Health Short Form measure
Change in satisfaction scores in couples in the TCU vs SUPPORT condition as assessed by the Satisfaction and Advantages/Drawbacks measure.
5 months baseline
Change in difference in fatigue scores in couples in the TCU vs SUPPORT condition as assessed by the 8-item PROMIS Fatigue measure.

Trial Safety

Safety Progress

1 of 3

Other trials for Heart Failure

Trial Design

2 Treatment Groups

SUPPORT
1 of 2
Taking Care of Us
1 of 2
Active Control
Experimental Treatment

144 Total Participants · 2 Treatment Groups

Primary Treatment: Taking Care of Us · No Placebo Group · N/A

Taking Care of Us
Behavioral
Experimental Group · 1 Intervention: Taking Care of Us · Intervention Types: Behavioral
SUPPORT
Other
ActiveComparator Group · 1 Intervention: SUPPORT · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 months baseline

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,380 Previous Clinical Trials
3,446,612 Total Patients Enrolled
38 Trials studying Heart Failure
213,082 Patients Enrolled for Heart Failure
Boston CollegeLead Sponsor
31 Previous Clinical Trials
23,852 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must be aged 18 years or older.\n
You have access to a telephone or email.
You have a diagnosis of heart failure for at least three months.
You have access to a device with a camera (e.g., computer, tablet) to participate in Zoom sessions.
You have a co-residing spouse/unmarried partner willing to participate.
You have lived with the adult with heart failure for at least one year.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: October 19th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.