Heart Failure
Conditions
Brief summary
The goals of this study are to determine the (1) feasibility and (2) acceptability of the 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.
Detailed description
Heart failure (HF) represents a significant public health concern. Medication non-adherence is 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. This study tests a values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation. The objective of this study is to examine the feasibility and acceptability of study procedures and the values-affirmation intervention in a pilot randomized controlled trial. Participants will complete a baseline assessment including 30 days of medication monitoring using electronic medication monitoring devices. After the baseline medication monitoring period, participants will be randomly assigned to either the intervention or control condition. Intervention participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills in additional to their usual cardiac rehabilitation care. Control participants will continue with their usual care. Participants will be asked to continue using the medication monitoring devices and to complete a final assessment 30 days later.
Interventions
BEHAVIORALValues Affirmation + Usual Care
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. The participant's study medication monitoring devices will be labeled with the participants' most important core value(s). Participants will also continue with their usual care.
OTHERUsual Care
Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Sponsors
National Institute on Aging (NIA)
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Heart failure * Enrolled in cardiac rehabilitation * Read and understand English
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention and Study Procedures | Post-test (2-months) | Participant self-reported satisfaction with intervention content and delivery \[intervention group only\] and study procedures |
| Retention | 2 months | Proportion of enrolled participants who completed the final assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence (Electronically Monitored) | 1 month; calculated as the difference between Baseline and post-test | Medication adherence will be electronically monitored. Adherence will be calculated as the overall percentage of days in which participants took their medications as prescribed during the monitoring period (30 days for baseline, 30 days post-intervention initiation) |
| Change in Medication Adherence (Self-report) | Baseline, post-test (2-months) | Self-reported medication adherence assessed with the Medication Adherence Scale (MAS; Wu et al., 2008). The MAS is a 32-item scale with three subscales - knowledge, attitudes, and barriers-- in addition to items assessing medication-taking behaviors. The 3 subscales are scored by summing items relevant to each subscale. Knowledge subscale scores range from 0 to 30; higher scores indicate greater medication knowledge. Attitudes subscale scores range from 0 to 40, with higher scores indicated report of a more positive attitude towards medication taking. The Barriers subscale scores range from 0 to 110, with higher scores indicated report of more barriers to taking medications as prescribed. |
| Medication Adherence (Pill Count) | Baseline, post-test (2-months) | Pill counts will be conducted on one medication |
Other
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Affect | Baseline, post-test (2-months) | Positive and Negative Affect Scale-Short Form (I-PANAS-SF). Two subscales are computed-- the positive affect score and the negative affect score. On both subscales, scores can range from 5 - 25 with higher scores indicating higher positive or negative affect, respectively. |
| Medication Self-Efficacy | Baseline, post-test (2-months) | Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions- Managing Medications and Treatment-Short Form 4a Raw scores range from 4 to 20; raw scores were transformed to T-scores with a mean of 50 and a standard deviation of 10. Higher scores reflect higher self-efficacy. |
| Perceived Stress-4 | Baseline, post-test (2-months) | Perceived Stress Scale- 4; total scores range from 0 to 16 with higher scores indicating greater perceived stress over the past month. |
| Disease-related Quality of Life | Baseline, post-test (2-months) | Minnesota Living with Heart Failure Questionnaire; Total scores range from 0 to 105. Higher scores indicate worse health status. |
| Change in General Quality of Life | Baseline, post-test (2-months) | EuroQual-5 Dimension (EQ-5D) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Values Affirmation + Usual Care Values Affirmation + Usual Care: 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. The participant's study medication monitoring devices will be labeled with the participants' most important core value(s). Participants will also continue with their usual care. | 21 |
| Usual Care Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management) | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Values Affirmation + Usual Care | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 68.67 years STANDARD_DEVIATION 7.73 | 68.43 years STANDARD_DEVIATION 9.13 | 68.19 years STANDARD_DEVIATION 10.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 41 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 34 Participants | 17 Participants |
| Region of Enrollment United States | 21 participants | 42 participants | 21 participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 15 Participants | 29 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 1 / 21 | 1 / 21 |
| serious Total, serious adverse events | 0 / 21 | 1 / 21 |
Outcome results
Primary
Acceptability of Intervention and Study Procedures
Participant self-reported satisfaction with intervention content and delivery \[intervention group only\] and study procedures
Time frame: Post-test (2-months)
Population: 2 losses to follow-up in intervention group; 1 person did not provide a response to overall acceptability of study procedures in the control group
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Values Affirmation + Usual Care | Acceptability of Intervention and Study Procedures | Overall Satisfaction with Intervention Content | 17 Participants |
| Values Affirmation + Usual Care | Acceptability of Intervention and Study Procedures | Overall Satisfaction with Study Procedures | 14 Participants |
| Usual Care | Acceptability of Intervention and Study Procedures | Overall Satisfaction with Study Procedures | 17 Participants |
Primary
Retention
Proportion of enrolled participants who completed the final assessment
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Values Affirmation + Usual Care | Retention | 19 Participants |
| Usual Care | Retention | 21 Participants |
Secondary
Change in Medication Adherence (Self-report)
Self-reported medication adherence assessed with the Medication Adherence Scale (MAS; Wu et al., 2008). The MAS is a 32-item scale with three subscales - knowledge, attitudes, and barriers-- in addition to items assessing medication-taking behaviors. The 3 subscales are scored by summing items relevant to each subscale. Knowledge subscale scores range from 0 to 30; higher scores indicate greater medication knowledge. Attitudes subscale scores range from 0 to 40, with higher scores indicated report of a more positive attitude towards medication taking. The Barriers subscale scores range from 0 to 110, with higher scores indicated report of more barriers to taking medications as prescribed.
Time frame: Baseline, post-test (2-months)
Population: 2 participants lost to follow-up at posttest; 2 additional participants missing data at post test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Values Affirmation + Usual Care | Change in Medication Adherence (Self-report) | Baseline Attitude subscale | 36.67 score on a scale | Standard Deviation 4.55 |
| Values Affirmation + Usual Care | Change in Medication Adherence (Self-report) | Baseline knowledge subscale | 22.15 score on a scale | Standard Deviation 7.14 |
| Values Affirmation + Usual Care | Change in Medication Adherence (Self-report) | baseline barriers subscale | 21.90 score on a scale | Standard Deviation 30.05 |
| Values Affirmation + Usual Care | Change in Medication Adherence (Self-report) | posttest Attitude subscale | 38.21 score on a scale | Standard Deviation 2.49 |
| Values Affirmation + Usual Care | Change in Medication Adherence (Self-report) | posttest knowledge subscale | 25.16 score on a scale | Standard Deviation 4.97 |
| Values Affirmation + Usual Care | Change in Medication Adherence (Self-report) | posttest barriers subscale | 16.76 score on a scale | Standard Deviation 30.03 |
| Usual Care | Change in Medication Adherence (Self-report) | posttest knowledge subscale | 22.19 score on a scale | Standard Deviation 7.28 |
| Usual Care | Change in Medication Adherence (Self-report) | Baseline Attitude subscale | 38.05 score on a scale | Standard Deviation 2.62 |
| Usual Care | Change in Medication Adherence (Self-report) | posttest Attitude subscale | 38.90 score on a scale | Standard Deviation 1.26 |
| Usual Care | Change in Medication Adherence (Self-report) | Baseline knowledge subscale | 20.76 score on a scale | Standard Deviation 8.98 |
| Usual Care | Change in Medication Adherence (Self-report) | posttest barriers subscale | 28.00 score on a scale | Standard Deviation 37.92 |
| Usual Care | Change in Medication Adherence (Self-report) | baseline barriers subscale | 22.00 score on a scale | Standard Deviation 32.21 |
Secondary
Medication Adherence (Electronically Monitored)
Medication adherence will be electronically monitored. Adherence will be calculated as the overall percentage of days in which participants took their medications as prescribed during the monitoring period (30 days for baseline, 30 days post-intervention initiation)
Time frame: 1 month; calculated as the difference between Baseline and post-test
Population: participants with missing data or data suggestive of non-use (e.g., 3 SDs below mean) excluded
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Values Affirmation + Usual Care | Medication Adherence (Electronically Monitored) | Baseline | 90.27 percentage of days adherent to regimen | Standard Deviation 14.51 |
| Values Affirmation + Usual Care | Medication Adherence (Electronically Monitored) | Posttest | 89.15 percentage of days adherent to regimen | Standard Deviation 19.45 |
| Usual Care | Medication Adherence (Electronically Monitored) | Baseline | 88.64 percentage of days adherent to regimen | Standard Deviation 17.53 |
| Usual Care | Medication Adherence (Electronically Monitored) | Posttest | 83.14 percentage of days adherent to regimen | Standard Deviation 19.51 |
Secondary
Medication Adherence (Pill Count)
Pill counts will be conducted on one medication
Time frame: Baseline, post-test (2-months)
Other Pre-specified
Change in General Quality of Life
EuroQual-5 Dimension (EQ-5D)
Time frame: Baseline, post-test (2-months)
Other Pre-specified
Disease-related Quality of Life
Minnesota Living with Heart Failure Questionnaire; Total scores range from 0 to 105. Higher scores indicate worse health status.
Time frame: Baseline, post-test (2-months)
Population: 2 participants missing data at post test due to loss to follow-up; 3 additional participants missing data for total score at post test
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Values Affirmation + Usual Care | Disease-related Quality of Life | Baseline | 26.59 score on a scale | Standard Deviation 17.91 |
| Values Affirmation + Usual Care | Disease-related Quality of Life | Posttest | 21.50 score on a scale | Standard Deviation 26.02 |
| Usual Care | Disease-related Quality of Life | Baseline | 33.33 score on a scale | Standard Deviation 20.41 |
| Usual Care | Disease-related Quality of Life | Posttest | 27.71 score on a scale | Standard Deviation 20.27 |
Other Pre-specified
Medication Self-Efficacy
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions- Managing Medications and Treatment-Short Form 4a Raw scores range from 4 to 20; raw scores were transformed to T-scores with a mean of 50 and a standard deviation of 10. Higher scores reflect higher self-efficacy.
Time frame: Baseline, post-test (2-months)
Population: missing data for 1 participant at baseline;
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Values Affirmation + Usual Care | Medication Self-Efficacy | Baseline | 59.16 score on a scale | Standard Deviation 6.16 |
| Values Affirmation + Usual Care | Medication Self-Efficacy | posttest | 58.45 score on a scale | Standard Deviation 5.8 |
| Usual Care | Medication Self-Efficacy | posttest | 58.76 score on a scale | Standard Deviation 5.61 |
| Usual Care | Medication Self-Efficacy | Baseline | 55.97 score on a scale | Standard Deviation 6.4 |
Other Pre-specified
Perceived Stress-4
Perceived Stress Scale- 4; total scores range from 0 to 16 with higher scores indicating greater perceived stress over the past month.
Time frame: Baseline, post-test (2-months)
Population: 2 participants lost to follow-up and missing posttest data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Values Affirmation + Usual Care | Perceived Stress-4 | Baseline | 3.76 score on a scale | Standard Deviation 3.42 |
| Values Affirmation + Usual Care | Perceived Stress-4 | Post-Test | 3.47 score on a scale | Standard Deviation 2.74 |
| Usual Care | Perceived Stress-4 | Post-Test | 3.00 score on a scale | Standard Deviation 3.24 |
| Usual Care | Perceived Stress-4 | Baseline | 3.86 score on a scale | Standard Deviation 3.25 |
Other Pre-specified
Positive and Negative Affect
Positive and Negative Affect Scale-Short Form (I-PANAS-SF). Two subscales are computed-- the positive affect score and the negative affect score. On both subscales, scores can range from 5 - 25 with higher scores indicating higher positive or negative affect, respectively.
Time frame: Baseline, post-test (2-months)
Population: 2 participants lost to follow-up and missing posttest data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Values Affirmation + Usual Care | Positive and Negative Affect | Positive Affect, Posttest | 18.74 score on a scale | Standard Deviation 4.51 |
| Values Affirmation + Usual Care | Positive and Negative Affect | Positive affect, Baseline | 19.29 score on a scale | Standard Deviation 3.88 |
| Values Affirmation + Usual Care | Positive and Negative Affect | Negative Affect, Baseline | 7.76 score on a scale | Standard Deviation 2.74 |
| Values Affirmation + Usual Care | Positive and Negative Affect | Negative Affect, Posttest | 7.63 score on a scale | Standard Deviation 2.01 |
| Usual Care | Positive and Negative Affect | Negative Affect, Posttest | 7.33 score on a scale | Standard Deviation 2.46 |
| Usual Care | Positive and Negative Affect | Positive affect, Baseline | 18.57 score on a scale | Standard Deviation 5.66 |
| Usual Care | Positive and Negative Affect | Positive Affect, Posttest | 19.81 score on a scale | Standard Deviation 4.52 |
| Usual Care | Positive and Negative Affect | Negative Affect, Baseline | 8.33 score on a scale | Standard Deviation 3.26 |