Heart FailureNCT05575375
Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure
A study of Heart Failure, run by The Miriam Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2022to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure
- Enrolled in cardiac rehabilitation
- Read and understand English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Controlled Trial of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Values Affirmation + Usual Care, Usual Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Values Affirmation + Usual CareBehavioural
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.
Usual CareOther
Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
| Study group | Role | What they receive |
|---|---|---|
| Values Affirmation + Usual Care | Experimental | Not described Receives: Behavioral: Values Affirmation + Usual Care |
| Usual Care | Other | Not described Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention and Study Procedures
Participant self-reported satisfaction with intervention content and delivery [intervention group only] and study procedures
Measured: Post-test (2-months)
Retention
Proportion of enrolled participants who completed the final assessment
Measured: 2 months
Secondary outcomes (3)
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)
Measured: 1 month; calculated as the difference between Baseline and post-test
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.
Measured: Baseline, post-test (2-months)
Medication Adherence (Pill Count)
Pill counts will be conducted on one medication
Measured: Baseline, post-test (2-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start15 Sep 2022
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575375
- Sponsor's protocol ID
- K23AG061214
- Other IDs
- K23AG061214
- Status last verified
- Jan 2025
- First submitted
- 3 Oct 2022
- Last updated
- 24 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT05575375
- Acronym / sponsor ID
- K23AG061214
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 12 Oct 2022 (actual)
- Results
- Posted 24 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Values Affirmation + Usual Care | Experimental | Behavioral: Values Affirmation + Usual Care |
| Usual Care | Other | Other: Usual Care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heart failure
- Enrolled in cardiac rehabilitation
- Read and understand English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Values Affirmation + Usual CareParticipants 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. | Behavioural | Values Affirmation + Usual Care |
| Usual CareParticipants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management) | Other | Usual Care |
Primary outcome
Acceptability of Intervention and Study Procedures
Time frame: Post-test (2-months)
Participant self-reported satisfaction with intervention content and delivery [intervention group only] and study procedures
Retention
Time frame: 2 months
Proportion of enrolled participants who completed the final assessment
3 secondary outcomes
Medication Adherence (Electronically Monitored)
Time frame: 1 month; calculated as the difference between Baseline and post-test
Change in Medication Adherence (Self-report)
Time frame: Baseline, post-test (2-months)
Medication Adherence (Pill Count)
Time frame: Baseline, post-test (2-months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Heart Failure, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention and Study Procedures (time frame: Post-test (2-months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.