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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-test (2-months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-test (2-months)
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 moreAwards & 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
245 Previous Clinical Trials
37,848 Total Patients Enrolled
3 Trials studying Heart Failure
206 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,803 Previous Clinical Trials
28,194,461 Total Patients Enrolled
43 Trials studying Heart Failure
213,430 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently enrolled in a cardiac rehabilitation program.I have the most severe form of heart failure.I have heart failure.You have been diagnosed with Alzheimer's, dementia, or severe memory problems.You are currently feeling very sad or having thoughts about hurting yourself, or you are experiencing problems with your thoughts and emotions.I have heart failure.
Research Study Groups:
This trial has the following groups:- Group 1: Values Affirmation + Usual Care
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.