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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-test (2-months)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
238 Previous Clinical Trials
37,425 Total Patients Enrolled
3 Trials studying Heart Failure
206 Patients Enrolled for Heart Failure
National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,855 Total Patients Enrolled
42 Trials studying Heart Failure
213,265 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

Frequently Asked Questions

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

Are new volunteers being enlisted in this research project?

"Confirmed, the data available on clinicaltrials.gov verifies that this clinical trial is actively seeking patients. The study was posted to the site on September 15th 2022 and has since been updated as of October 10th 2022. 50 participants need to be recruited from 1 medical centre."

Answered by AI

What is the participant count for this experiment?

"Affirmative, the information posted on clinicaltrials.gov shows that this research is actively searching for participants. The project was initially published on September 15th 2022 and revised most recently on October 10th 2022; it seeks 50 patients from a single location."

Answered by AI

Who else is applying?

What site did they apply to?
The Miriam Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure
2022. "Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05575375.
~17 spots leftby Mar 2025
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