An interventional study of Values-Affirmation in Heart Failure, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Other
Heart failure (HF) represents a significant public health concern. Medication non-adherence represents a modifiable contributor to costly hospital readmissions in older adults with HF. Educational interventions improve, but do not eliminate, non-adherence. Values affirmation interventions which invite individuals to reflect on core values may encourage better engagement in health behaviors by increasing the personal relevance of targeted behaviors. Similar interventions have promoted weight loss, increased adherence and physical activity, and more frequent fruit and vegetable consumption in a variety of contexts and populations. This study seeks to test a recently developed values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation (CR). The purpose of this feasibility study is to test methodology to aid development of a subsequent randomized controlled pilot trial to examine preliminary efficacy.
The objective of this study is to examine the preliminary feasibility and acceptability of study procedures and the values-affirmation intervention in a single-arm trial. Participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills. Participants will complete a baseline assessment and a follow-up assessment at one month post-intervention. The investigators hypothesize that the developed study and intervention procedures will be feasible and acceptable to participants. The investigators will also examine changes in self-reported and electronically monitored medication adherence from the baseline assessment to follow-up.
5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 7 is below the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →The Miriam Hospital is the lead sponsor of 182 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Behavioral: Values-Affirmation
Participants will engage in a brief values-affirmation exercise to target personal motivation and openness to medication adherence. The interventionist will then review tailored medication education and individual skills training recommendations. Following the intervention session, participants will receive electronic pill box(es) that are labeled with the participants' most important core value(s) and will be asked to use these pill box(es) to take their HF medications for 4 weeks.
Feasibility of Recruitment Procedures
Proportion of eligible participants who enroll in the study
Time frame: Baseline
Feasibility of Intervention Procedures
Proportion of enrolled participants who complete the study
Time frame: Week 4
Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed Interview
Qualitative exit interview to assess patient reported satisfaction with intervention content, intervention delivery, and study procedures
Time frame: Week 4
Self-reported Medication Adherence
Timeline follow-back interview
Time frame: Baseline, 4 weeks
| Milestone | Values-affirmation |
|---|---|
| Started | 7 |
| Completed | 6 |
| Not completed | 1 |
Proportion of eligible participants who enroll in the study
| Participants | Values-affirmation |
|---|---|
| Feasibility of Recruitment Procedures | 7 |
Proportion of enrolled participants who complete the study
| Participants | Values-affirmation |
|---|---|
| Feasibility of Intervention Procedures | 6 |
Qualitative exit interview to assess patient reported satisfaction with intervention content, intervention delivery, and study procedures
| Participants | Values-affirmation |
|---|---|
| Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed Interview | 7 |
Timeline follow-back interview
| percent adherence | Values-affirmation |
|---|---|
| Baseline | 96.69 ± 3.82 |
| 4 weeks | 99.05 ± 2.13 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Values-affirmation | 0/7 (0%) | 1/7 (14.3%) | 1/7 (14.3%) |
| Event | Values-affirmation |
|---|---|
| Chest pain- cardiacCardiac disorders | 1/7 |
| Event | Values-affirmation |
|---|---|
| DiarrheaGastrointestinal disorders | 1/7 |
| Age, Continuous(years) | Values-affirmation |
|---|---|
| Mean | 75.5 ± 8.76 |
| Sex: Female, Male(Participants) | Values-affirmation |
|---|---|
| Female | 1 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Values-affirmation |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Values-affirmation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Values-affirmation |
|---|---|
| United States | 7 |
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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