Trial Outcomes & Findings for Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure (NCT NCT05310877)

NCT ID: NCT05310877

Last Updated: 2023-06-22

Results Overview

Proportion of eligible participants who enroll in the study

Recruitment status

COMPLETED

Study phase

Target enrollment

7 participants

Primary outcome timeframe

Baseline

Results posted on

2023-06-22

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	7
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Missing data for 1 participant on age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Values-affirmation n=7 Participants 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.
Age, Continuous	75.5 years STANDARD_DEVIATION 8.76 • n=6 Participants • Missing data for 1 participant on age
Sex: Female, Male Female	1 Participants n=7 Participants
Sex: Female, Male Male	6 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants
Race (NIH/OMB) Asian	1 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	2 Participants n=7 Participants
Race (NIH/OMB) White	4 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants
Region of Enrollment United States	7 participants n=7 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Number of participants who completed eligibility screening and met all study criteria

Proportion of eligible participants who enroll in the study

Outcome measures

Outcome measures
Measure	Values-affirmation n=10 Participants 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.
Feasibility of Recruitment Procedures	7 Participants

PRIMARY outcome

Timeframe: Week 4

Proportion of enrolled participants who complete the study

Outcome measures

Outcome measures
Measure	Values-affirmation n=7 Participants 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.
Feasibility of Intervention Procedures	6 Participants

PRIMARY outcome

Timeframe: Week 4

Qualitative exit interview to assess patient reported satisfaction with intervention content, intervention delivery, and study procedures

Outcome measures

Outcome measures
Measure	Values-affirmation n=7 Participants 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.
Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed Interview	7 Participants

SECONDARY outcome

Timeframe: Baseline, 4 weeks

Population: At 4 weeks, 2 participants refused to complete EOT survey

Timeline follow-back interview

Outcome measures

Outcome measures
Measure	Values-affirmation n=7 Participants 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.
Self-reported Medication Adherence Baseline	96.69 percent adherence Standard Deviation 3.82
Self-reported Medication Adherence 4 weeks	99.05 percent adherence Standard Deviation 2.13

Adverse Events

Values-affirmation

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Values-affirmation n=7 participants at risk 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.
Cardiac disorders Chest pain- cardiac	14.3% 1/7 • 1 month

Other adverse events

Other adverse events
Measure	Values-affirmation n=7 participants at risk 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.
Gastrointestinal disorders Diarrhea	14.3% 1/7 • 1 month

Additional Information

Emily Gathright, PhD

The Miriam Hospital

Phone: 401-793-8271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place