Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies

ConditionsMedication Adherence Heart Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorJia-Rong Wu

About this trial

People with heart failure who do not take their medications as prescribed are at high risk of complications leading to hospitalization, death and poor quality of life. In the proposed intervention, nurses will use easy-to-understand language to coach patients and their care partners to help them work together and build skills to overcome their individual barriers to adherence in order to 1) improve and sustain patient medication adherence; 2) reduce hospitalization; 3) improve quality of life. If effective, this intervention will support long-term medication adherence, thus reducing hospitalizations related to heart failure and quality of life.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

confirmed diagnosis of heart failure (HF), either systolic or diastolic HF

ave suboptimal medication adherence

have a care partner (CP) (either spouse, daughter/son, partner, other relative, friend) who is identified by the patient as the person most involved in HF care

willingness to have a CP be involved in their medication taking

Disqualifiers

cognitive impairment as indicated by having difficulties to understand and give informed consent

a recent hospitalization within 3 months of study enrollment

co-existing end-stage renal disease or terminal illness such as advanced malignancy, or any other condition with less than 1-year life expectancy

psychotic illness

Trial design

Design model

Parallel

Treatments tested in this trial

FamLit
Behavioral
The FamLit (Family-focused and Literacy-sensitive strategy) is an interactive, multi-component intervention supported by the FamLit intervention Guide, including both spoken and printed materials written at a 4th-grade reading level for HF patients and their primary CPs.Three constructs guide the intervention, based on the Theory of Planned Behavior (TPB): 1) develop patient and CP positive attitudes through HF instruction and teach-back; 2) form positive subjective norms through coaching to improve patient and CP communication, support, and teamwork; and 3) increase perceived behavioral control through coaching and role-playing to empower patients and CPs to overcome individual barriers to adherence. This intervention also includes use of the SimpleMed+ electronic pillbox.
Attention Control
Behavioral
Participants in this group will talk with an interventionist to discuss general health. This intervention also includes use of the SimpleMed+ electronic pillbox.

Treatment groups

328 Participants

are divided into 4 treatment groups

Group A: Patients - Attention OnlyActive comparator 1 intervention

Group B: Care Partners - Attention OnlyActive comparator 1 intervention

Group C: Patients - FamLitExperimental treatment 1 intervention

Group D: Care Partners - FamLitExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Medication adherence

Percentage of prescribed doses taken (PDT%) as determined by the electronic SimpleMed+ pillbox. SimpleMed+ will record the date and time that the lid of each compartment is opened and closed. Those data will be used to calculate objective medication adherence: percent prescribed doses taken (PDT%) = (# of doses taken during monitoring period)/(# of prescribed doses during monitoring period) x 100.PDT% ranges from 0-100%.

Time frame

12 months

Self-reported medication adherence.

Adherence will be surveyed the Basel Assessment of Adherence Scale (BAAS), a copyrighted, self-reported scale. The BAAS includes 5 yes-no items and one visual analogue scale (VAS). If participants indicate they have missed a dose (a "yes" response) to any of 5 dichotomous items and \<80% on the VAS, they are classified as suboptimally medication adherent.

Time frame

12 months

Secondary outcomes

Patient hospitalization

Percentage of patients hospitalized. HF hospitalizations will be determined by a combination of medical record review and monthly phone interviews with patients and/or care partners to collect data for all encounters.

Time frame

12 months

Quality of life - Minnesota Living with Heart Failure

The 21-item Minnesota Living with Heart Failure (MLHF) questionnaire measures the patient's perceptions of the influence of HF on physical and emotional aspects of life. The items are scored on a Likert scale from 0 (No) to 5 (Very much). The scores of the 21 items will be summed with higher scores of the MLHF indicating worse quality of life.

Time frame

12 months

Positive Affect

Generic quality of life will be assessed using the NeuroQoL Positive Affect and Well-Being short form, which has 9 items and each item is rated on a 5-point Likert scale from 1 (never) to 5 (always); higher scores indicate better quality of life.

Time frame

12 months

Other outcomes

Caregiver Burden

The Zarit Caregiver Burden Interview (ZBI) measures caregiver burden. The ZBI has 12 items and each item is rated on a 5-point Likert scale from 0 (never) to 4 (always); higher scores indicate higher caregiver burden.

Time frame

12 months

Numeracy health literacy

The Newest Vital Sign (NVS) will be used to assess numeracy. Participants will be given a nutritional label and be asked 6 questions about its content. Participants will get one point for each question they are correct. Participants will be scored on the number of questions they get correct, higher scores indicate better numeracy health literacy.

Time frame

12 months

Health Literacy

The 36-item Short Test of Functional Health Literacy in Adults (S-TOFHLA),which has 36-items. Participants will be scored on the number of items they got correct (one point for each correct item), higher scores indicate better health literacy. Patients and CPs will be categorized as low (0-22) or high (23-36) health literacy.

Time frame

12 months

Medication Adherence Scale

The psychometrically sound Medication Adherence Scale (MAS) with 3 subscales to measure constructs of the Theory of Planned Behavior. The Attitude subscale has 7 items on a Likert scale from 0 (strongly disagree) to 10 (strongly agree), higher scores indicate better attitudes. The Subjective Norm subscale has 4 items on a Likert scale from 1 (strongly disagree) to 5 (strongly agree), higher scores indicate more positive subjective norm. The Perceived Behavioral Control subscale has 12 items on a Likert scale from 0 (never being a cause) to 10 (very important cause), higher scores indicate more barriers.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jia-Rong Wu

Lead sponsor

The University of Tennessee, Knoxville

Sponsor institution

National Institute of Nursing Research (NINR)

Collaborator

Source ClinicalTrials.gov

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