Trial results for a study investigating a values-affirmation and education intervention targeting medication adherence in older adults with Heart Failure were posted on ClinicalTrials.gov on 2025-11-24, with 43 participants enrolled.
Background
Heart failure is a chronic condition requiring consistent medication adherence to manage symptoms and prevent disease progression. Poor medication adherence is a significant challenge in patient care, often leading to worse health outcomes and increased healthcare utilization. Interventions designed to improve adherence are therefore critical for optimizing the management of heart failure, particularly in older adult populations.
Trial design
This completed study, designated as Phase NA, enrolled 43 participants with Heart Failure. The trial aimed to determine the feasibility and acceptability of study procedures through a pilot randomized controlled trial of a values affirmation intervention targeting medication adherence in adults with heart failure enrolled in cardiac rehabilitation, relative to usual care. The intervention involved a "Values Affirmation + Usual Care" arm compared to a "Usual Care" arm.
Key results
The trial reported several key measurements:
- Acceptability of Intervention and Study Procedures (Count of Participants):
- In the Values Affirmation + Usual Care group, 17 participants and 14 participants were reported.
- In the Usual Care group, 17 participants were reported.
- Retention (Count of Participants):
- In the Values Affirmation + Usual Care group, 19 participants were retained.
- In the Usual Care group, 21 participants were retained.
- Medication Adherence (Electronically Monitored) (percentage of days adherent to regimen):
- In the Values Affirmation + Usual Care group, a mean of 90.27 (Standard Deviation 14.51) and a mean of 89.15 (Standard Deviation 19.45) were observed.
- In the Usual Care group, a mean of 88.64 (Standard Deviation 17.53) and a mean of 83.14 (Standard Deviation 19.51) were observed.
- Change in Medication Adherence (Self-report) (score on a scale):
- In the Values Affirmation + Usual Care group, a mean of 36.67 (Standard Deviation 4.55) and a mean of 22.15 (Standard Deviation 7.14) were observed.
- In the Usual Care group, a mean of 38.05 (Standard Deviation 2.62) was observed.
What this means
The posted results from this pilot study provide initial data on the feasibility and acceptability of a values-affirmation intervention for improving medication adherence in older adults with heart failure. While the study's primary objectives focused on feasibility and acceptability, the electronic monitoring data for medication adherence showed that participants in the Values Affirmation + Usual Care group had mean adherence percentages of 90.27% (Standard Deviation 14.51%) and 89.15% (Standard Deviation 19.45%), which were numerically higher than those in the Usual Care group, which reported mean adherence percentages of 88.64% (Standard Deviation 17.53%) and 83.14% (Standard Deviation 19.51%). These findings suggest potential for the intervention to positively influence adherence, warranting further investigation in larger trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05575375, titled "Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure", were posted on 2025-11-24 on clinicaltrials.gov.