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Values-Affirmation + Education for Heart Failure

N/A
Recruiting
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients enrolled in cardiac rehabilitation
Patients with heart failure
Must not have
Patients with New York Heart Association class IV heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-test (2-months)
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a positive values affirmation intervention helps adults with heart failure adhere to their medication better than usual care.

Who is the study for?
This trial is for older adults with heart failure who are currently enrolled in cardiac rehabilitation and can read and understand English. It's not open to those with the most severe heart failure (NYHA class IV), Alzheimer's, dementia, severe cognitive impairment, current suicidality or psychosis, or those already in another medication-monitoring study.
What is being tested?
The study is testing a new approach called 'Values Affirmation' combined with usual care against just usual care alone. The aim is to see if this intervention helps patients stick to their heart medication better during cardiac rehab.
What are the potential side effects?
Since the intervention involves non-medical techniques aimed at improving adherence to prescribed medications rather than introducing new drugs, no direct side effects from the Values Affirmation process itself are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently enrolled in a cardiac rehabilitation program.
Select...
I have heart failure.
Select...
I have heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have the most severe form of heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-test (2-months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-test (2-months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of intervention and study procedures
Feasibility of recruitment and retention
Secondary study objectives
Contraceptives, Oral
Change in Medication Adherence (electronically monitored)
Change in Medication Adherence (self-report)
Other study objectives
Change in Depressive symptoms
Change in Disease-related Quality of Life
Change in General Quality of Life
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Values Affirmation + Usual CareExperimental Treatment1 Intervention
Group II: Usual CareExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

The Miriam HospitalLead Sponsor
244 Previous Clinical Trials
37,828 Total Patients Enrolled
3 Trials studying Heart Failure
206 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,282 Total Patients Enrolled
43 Trials studying Heart Failure
213,430 Patients Enrolled for Heart Failure

Media Library

Values Affirmation Clinical Trial Eligibility Overview. Trial Name: NCT05575375 — N/A
Heart Failure Research Study Groups: Values Affirmation + Usual Care, Usual Care
Heart Failure Clinical Trial 2023: Values Affirmation Highlights & Side Effects. Trial Name: NCT05575375 — N/A
Values Affirmation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05575375 — N/A
~5 spots leftby Mar 2025
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