Heart Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALValues-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.
Sponsors
National Institute on Aging (NIA)
The Miriam Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Heart failure * Enrolled in cardiac rehabilitation * Read and understand English * At risk for medication non-adherence based on self-report screening or number of prescribed medications
Exclusion criteria
* Current participation in another medication-monitoring clinical or research protocol * New York Heart Association class IV heart failure * Diagnosis of Alzheimer's, dementia, or severe cognitive impairment indicated on screening * Current suicidality or psychosis * Terminal illness with an expected lifespan of less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Recruitment Procedures | Baseline | Proportion of eligible participants who enroll in the study |
| Feasibility of Intervention Procedures | Week 4 | Proportion of enrolled participants who complete the study |
| Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed Interview | Week 4 | Qualitative exit interview to assess patient reported satisfaction with intervention content, intervention delivery, and study procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Medication Adherence | Baseline, 4 weeks | Timeline follow-back interview |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Values-affirmation 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. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Values-affirmation |
|---|---|
| Age, Continuous | 75.5 years STANDARD_DEVIATION 8.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 1 / 7 |
| serious Total, serious adverse events | 1 / 7 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Values-affirmation | Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed Interview | 7 Participants |
Primary
Feasibility of Intervention Procedures
Proportion of enrolled participants who complete the study
Time frame: Week 4
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Values-affirmation | Feasibility of Intervention Procedures | 6 Participants |
Primary
Feasibility of Recruitment Procedures
Proportion of eligible participants who enroll in the study
Time frame: Baseline
Population: Number of participants who completed eligibility screening and met all study criteria
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Values-affirmation | Feasibility of Recruitment Procedures | 7 Participants |
Secondary
Self-reported Medication Adherence
Timeline follow-back interview
Time frame: Baseline, 4 weeks
Population: At 4 weeks, 2 participants refused to complete EOT survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Values-affirmation | Self-reported Medication Adherence | Baseline | 96.69 percent adherence | Standard Deviation 3.82 |
| Values-affirmation | Self-reported Medication Adherence | 4 weeks | 99.05 percent adherence | Standard Deviation 2.13 |