Trial Outcomes & Findings for Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure (NCT NCT05575375)

NCT ID: NCT05575375

Last Updated: 2025-11-24

Results Overview

Participant self-reported satisfaction with intervention content and delivery \[intervention group only\] and study procedures

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: Post-test (2-months)
• Results posted on: 2025-11-24

Participant Flow

Participant milestones

Measure	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.	Usual Care Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Overall Study STARTED	21	21
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Values-Affirmation + Education Intervention Targeting Medication Adherence in Older Adults With Heart Failure

Baseline characteristics by cohort

Measure	Values Affirmation + Usual Care n=21 Participants 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.	Usual Care n=21 Participants Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)	Total n=42 Participants Total of all reporting groups
Age, Continuous	68.67 years STANDARD_DEVIATION 7.73 • n=45 Participants	68.19 years STANDARD_DEVIATION 10.54 • n=12929 Participants	68.43 years STANDARD_DEVIATION 9.13 • n=6349 Participants
Sex: Female, Male Female	6 Participants n=45 Participants	7 Participants n=12929 Participants	13 Participants n=6349 Participants
Sex: Female, Male Male	15 Participants n=45 Participants	14 Participants n=12929 Participants	29 Participants n=6349 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=45 Participants	21 Participants n=12929 Participants	41 Participants n=6349 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=45 Participants	0 Participants n=12929 Participants	1 Participants n=6349 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants	1 Participants n=12929 Participants	1 Participants n=6349 Participants
Race (NIH/OMB) Asian	1 Participants n=45 Participants	0 Participants n=12929 Participants	1 Participants n=6349 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race (NIH/OMB) Black or African American	2 Participants n=45 Participants	1 Participants n=12929 Participants	3 Participants n=6349 Participants
Race (NIH/OMB) White	17 Participants n=45 Participants	17 Participants n=12929 Participants	34 Participants n=6349 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants	2 Participants n=12929 Participants	2 Participants n=6349 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=45 Participants	0 Participants n=12929 Participants	1 Participants n=6349 Participants
Region of Enrollment United States	21 participants n=45 Participants	21 participants n=12929 Participants	42 participants n=6349 Participants

PRIMARY outcome

Timeframe: 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

Participant self-reported satisfaction with intervention content and delivery [intervention group only] and study procedures

Outcome measures

Measure	Values Affirmation + Usual Care n=17 Participants 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.	Usual Care n=20 Participants Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Acceptability of Intervention and Study Procedures Overall Satisfaction with Intervention Content	17 Participants	—
Acceptability of Intervention and Study Procedures Overall Satisfaction with Study Procedures	14 Participants	17 Participants

PRIMARY outcome

Timeframe: 2 months

Proportion of enrolled participants who completed the final assessment

Outcome measures

Measure	Values Affirmation + Usual Care n=21 Participants 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.	Usual Care n=21 Participants Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Retention	19 Participants	21 Participants

SECONDARY outcome

Timeframe: 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

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)

Outcome measures

Measure	Values Affirmation + Usual Care n=15 Participants 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.	Usual Care n=14 Participants Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Medication Adherence (Electronically Monitored) Baseline	90.27 percentage of days adherent to regimen Standard Deviation 14.51	88.64 percentage of days adherent to regimen Standard Deviation 17.53
Medication Adherence (Electronically Monitored) Posttest	89.15 percentage of days adherent to regimen Standard Deviation 19.45	83.14 percentage of days adherent to regimen Standard Deviation 19.51

SECONDARY outcome

Timeframe: Baseline, post-test (2-months)

Population: 2 participants lost to follow-up at posttest; 2 additional participants missing data at post test

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.

Outcome measures

Measure	Values Affirmation + Usual Care n=21 Participants 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.	Usual Care n=21 Participants Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Change in Medication Adherence (Self-report) Baseline Attitude subscale	36.67 score on a scale Standard Deviation 4.55	38.05 score on a scale Standard Deviation 2.62
Change in Medication Adherence (Self-report) Baseline knowledge subscale	22.15 score on a scale Standard Deviation 7.14	20.76 score on a scale Standard Deviation 8.98
Change in Medication Adherence (Self-report) baseline barriers subscale	21.90 score on a scale Standard Deviation 30.05	22.00 score on a scale Standard Deviation 32.21
Change in Medication Adherence (Self-report) posttest Attitude subscale	38.21 score on a scale Standard Deviation 2.49	38.90 score on a scale Standard Deviation 1.26
Change in Medication Adherence (Self-report) posttest knowledge subscale	25.16 score on a scale Standard Deviation 4.97	22.19 score on a scale Standard Deviation 7.28
Change in Medication Adherence (Self-report) posttest barriers subscale	16.76 score on a scale Standard Deviation 30.03	28.00 score on a scale Standard Deviation 37.92

SECONDARY outcome

Timeframe: Baseline, post-test (2-months)

Pill counts will be conducted on one medication

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, post-test (2-months)

Population: 2 participants lost to follow-up and missing posttest data

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.

Outcome measures

Measure	Values Affirmation + Usual Care n=21 Participants 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.	Usual Care n=21 Participants Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Positive and Negative Affect Negative Affect, Posttest	7.63 score on a scale Standard Deviation 2.01	7.33 score on a scale Standard Deviation 2.46
Positive and Negative Affect Positive affect, Baseline	19.29 score on a scale Standard Deviation 3.88	18.57 score on a scale Standard Deviation 5.66
Positive and Negative Affect Positive Affect, Posttest	18.74 score on a scale Standard Deviation 4.51	19.81 score on a scale Standard Deviation 4.52
Positive and Negative Affect Negative Affect, Baseline	7.76 score on a scale Standard Deviation 2.74	8.33 score on a scale Standard Deviation 3.26

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, post-test (2-months)

Population: 2 participants lost to follow-up and missing posttest data

Perceived Stress Scale- 4; total scores range from 0 to 16 with higher scores indicating greater perceived stress over the past month.

Outcome measures

Measure	Values Affirmation + Usual Care n=21 Participants 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.	Usual Care n=21 Participants Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Perceived Stress-4 Baseline	3.76 score on a scale Standard Deviation 3.42	3.86 score on a scale Standard Deviation 3.25
Perceived Stress-4 Post-Test	3.47 score on a scale Standard Deviation 2.74	3.00 score on a scale Standard Deviation 3.24

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, post-test (2-months)

Population: missing data for 1 participant at baseline;

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.

Outcome measures

Measure	Values Affirmation + Usual Care n=20 Participants 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.	Usual Care n=21 Participants Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Medication Self-Efficacy Baseline	59.16 score on a scale Standard Deviation 6.16	55.97 score on a scale Standard Deviation 6.40
Medication Self-Efficacy posttest	58.45 score on a scale Standard Deviation 5.80	58.76 score on a scale Standard Deviation 5.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Minnesota Living with Heart Failure Questionnaire; Total scores range from 0 to 105. Higher scores indicate worse health status.

Outcome measures

Measure	Values Affirmation + Usual Care n=17 Participants 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.	Usual Care n=21 Participants Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Disease-related Quality of Life Baseline	26.59 score on a scale Standard Deviation 17.91	33.33 score on a scale Standard Deviation 20.41
Disease-related Quality of Life Posttest	21.50 score on a scale Standard Deviation 26.02	27.71 score on a scale Standard Deviation 20.27

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, post-test (2-months)

EuroQual-5 Dimension (EQ-5D)

Outcome measures

Outcome data not reported

Adverse Events

Values Affirmation + Usual Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Usual Care

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Values Affirmation + Usual Care n=21 participants at risk 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.	Usual Care n=21 participants at risk Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Cardiac disorders myocardial infarction	0.00% 0/21 • 2 months	4.8% 1/21 • 2 months

Other adverse events

Measure	Values Affirmation + Usual Care n=21 participants at risk 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.	Usual Care n=21 participants at risk Usual Care: Participants will be asked to continue with their usual care (e.g., cardiac rehabilitation, ongoing medical management)
Musculoskeletal and connective tissue disorders fall	0.00% 0/21 • 2 months	4.8% 1/21 • 2 months
Musculoskeletal and connective tissue disorders baker's cyst	4.8% 1/21 • 2 months	0.00% 0/21 • 2 months

Additional Information

Emily Gathright

The Miriam Hospital

Phone: 4017938271

Email: emily.gathright@brownhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place