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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG061214 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Values Affirmation + Usual Care | Experimental |
| |
| Usual Care | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Values Affirmation + Usual Care | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention and Study Procedures | Participant self-reported satisfaction with intervention content and delivery [intervention group only] and study procedures | Post-test (2-months) |
| Retention | Proportion of enrolled participants who completed the final assessment | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 month; calculated as the difference between Baseline and post-test |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-test (2-months) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acceptability of Intervention and Study Procedures | Participant self-reported satisfaction with intervention content and delivery [intervention group only] and study procedures | 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 | Posted | Count of Participants | Participants | Post-test (2-months) |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Gathright | The Miriam Hospital | 4017938271 | emily.gathright@brownhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2023 | Aug 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2022 | Aug 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Usual Care | Other | Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management) |
|
| 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. | Baseline, post-test (2-months) |
| Medication Adherence (Pill Count) | Pill counts will be conducted on one medication | Baseline, post-test (2-months) |
| 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. |
| Baseline, post-test (2-months) |
| 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. | Baseline, post-test (2-months) |
| Disease-related Quality of Life | Minnesota Living with Heart Failure Questionnaire; Total scores range from 0 to 105. Higher scores indicate worse health status. | Baseline, post-test (2-months) |
| Change in General Quality of Life | EuroQual-5 Dimension (EQ-5D) | Baseline, post-test (2-months) |
| BG001 | Usual Care | Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Usual Care | Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management) |
|
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| Primary | Retention | Proportion of enrolled participants who completed the final assessment | Posted | Count of Participants | Participants | 2 months |
|
|
|
| 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) | participants with missing data or data suggestive of non-use (e.g., 3 SDs below mean) excluded | Posted | Mean | Standard Deviation | percentage of days adherent to regimen | 1 month; calculated as the difference between Baseline and post-test |
|
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| 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. | 2 participants lost to follow-up at posttest; 2 additional participants missing data at post test | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-test (2-months) |
|
|
|
| Secondary | Medication Adherence (Pill Count) | Pill counts will be conducted on one medication | Not Posted | Baseline, post-test (2-months) | Participants |
| 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. | 2 participants lost to follow-up and missing posttest data | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-test (2-months) |
|
|
|
| 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. | 2 participants lost to follow-up and missing posttest data | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-test (2-months) |
|
|
|
| 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. | missing data for 1 participant at baseline; | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-test (2-months) |
|
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| 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. | 2 participants missing data at post test due to loss to follow-up; 3 additional participants missing data for total score at post test | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-test (2-months) |
|
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| Other Pre-specified | Change in General Quality of Life | EuroQual-5 Dimension (EQ-5D) | Not Posted | Baseline, post-test (2-months) | Participants |
| 0 |
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | Usual Care | Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management) | 0 | 21 | 1 | 21 | 1 | 21 |
| baker's cyst | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Posttest |
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| Baseline knowledge subscale |
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| baseline barriers subscale |
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| posttest Attitude subscale |
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| posttest knowledge subscale |
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| posttest barriers subscale |
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| Positive Affect, Posttest |
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| Negative Affect, Baseline |
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| Negative Affect, Posttest |
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