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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23AG061214 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Values-affirmation | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Values-Affirmation | 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. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment Procedures | Proportion of eligible participants who enroll in the study | Baseline |
| Feasibility of Intervention Procedures | Proportion of enrolled participants who complete the study | 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 | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Medication Adherence | Timeline follow-back interview | Baseline, 4 weeks |
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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 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Missing data for 1 participant on age |
| 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 | Feasibility of Recruitment Procedures | Proportion of eligible participants who enroll in the study | Number of participants who completed eligibility screening and met all study criteria | Posted | Count of Participants | Participants | Baseline |
|
1 month
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain- cardiac | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Gathright, PhD | The Miriam Hospital | 401-793-8271 | Emily.Gathright@lifespan.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 31, 2022 | May 30, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 31, 2022 | May 30, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Mean |
| Standard Deviation |
| 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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| Units | Counts |
|---|---|
| Participants |
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| Primary | Feasibility of Intervention Procedures | Proportion of enrolled participants who complete the study | Posted | Count of Participants | Participants | Week 4 |
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| 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 | Posted | Count of Participants | Participants | Week 4 |
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| Secondary | Self-reported Medication Adherence | Timeline follow-back interview | At 4 weeks, 2 participants refused to complete EOT survey | Posted | Mean | Standard Deviation | percent adherence | Baseline, 4 weeks |
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| 0 |
| 7 |
| 1 |
| 7 |
| 1 |
| 7 |
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