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

NCT ID: NCT05548413

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-04
• Study Completion Date: 2027-12-31

Brief Summary

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.

Detailed Description

Medication adherence is thought by many providers and researchers to be the most important self-care behavior, yet it is also the most problematic. Poor medication adherence can cause poor quality of life (QoL), hospitalization, and death. In the United States, approximately 125,000 deaths per year are due to poor medication adherence and up to 50% of heart failure (HF) patients are re-hospitalized within 6 months of a previous HF exacerbation and one of the most common causes is poor medication adherence. Lifelong and usually complex medication regimens are needed for patients with HF, yet 40-60% of HF patients have suboptimal medication adherence. Health literacy plays a significant role in suboptimal medication adherence. Support by a care partner (CP; usually a family member) can improve adherence and reduce hospitalizations. Although some interventions have improved HF patients' adherence, improvements were small, and effects were not sustained. To enhance and sustain intervention effects, an approach that is literacy-sensitive and incorporates social support will be used. Using easy-to-understand language for patients and CPs, investigators will test an interactive, behavioral, family-focused and literacy-sensitive (FamLit) intervention delivered by nurses, incorporating evidence-based, multi-components (e.g., teach-back, coaching, role-playing, goal setting) to engage both patients and CPs in improving and sustaining medication adherence and health outcomes. A randomized controlled trial will be conducted to evaluate the efficacy of FamLit intervention on medication adherence, hospitalization, death, and QoL. 164 dyads of patients and their primary CPs (patients-CPs) will be randomly assigned to either the FamLit intervention or an attention-control group. Both groups will have an in-person session (delivered on the day of a clinic appointment for regular follow-up) one month after baseline and phone boosters every other week for up to 3 months. FamLit group sessions will focus on improving medication adherence, and control group sessions will focus on general health issues. Aims are to: 1) test the efficacy of the FamLit intervention compared to an attention control group on outcomes (i.e., primary: medication adherence, and secondary: a) HF hospitalization or all-cause death, b) QoL over 12 months.

Conditions

Medication Adherence; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients - Attention Only

Patients with a confirmed diagnosis of heart failure.

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: BEHAVIORAL

Participants in this group will talk with an interventionist to discuss general health. This intervention also includes use of the SimpleMed+ electronic pillbox.

Care Partners - Attention Only

Care partners of patients with a confirmed diagnosis of heart failure.

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: BEHAVIORAL

Participants in this group will talk with an interventionist to discuss general health. This intervention also includes use of the SimpleMed+ electronic pillbox.

Patients - FamLit

Patients with a confirmed diagnosis of heart failure.

Group Type: EXPERIMENTAL

FamLit

Intervention Type: 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.

Care Partners - FamLit

Care partners of patients with a confirmed diagnosis of heart failure.

Group Type: EXPERIMENTAL

FamLit

Intervention Type: 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.

Interventions

FamLit

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.

Intervention Type: BEHAVIORAL

Attention Control

Participants in this group will talk with an interventionist to discuss general health. This intervention also includes use of the SimpleMed+ electronic pillbox.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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
• have undergone evaluation of HF and prescribed stable doses of HF medications for at least 3 months
• live in a setting where the patient is responsible for their ow medication administration
• willing to use the SimpleMed+ (i.e., an electronic pillbox to measure objective medication adherence)
• availability by phone

• unpaid family member, friend, partner, or other relation who is involved in the patients' care at least 3 times a week, designated by the patient
• willing to receive interventions with the patient together
• 18 years of age or older

Exclusion Criteria

• 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
• current alcohol dependence or other substance abuse
• inability to speak English or other communication barrier
• currently or have received any similar self-care intervention recently in the past year

• cognitive impairment as indicated by having difficulties to understand and give informed consent
• coexisting terminal illness
• non-English speaking or any other communication barrier

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Jia-Rong Wu

OTHER

Sponsor Role: lead

Responsible Party

Jia-Rong Wu

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jia-Rong Wu

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Jia-Rong Wu

Lexington, Kentucky, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jia-Rong Wu, PhD

Role: CONTACT

jiarong.wu2@uky.edu

8593234712

Facility Contacts

Jia-Rong Wu, PhD

Role: primary

jiarong.wu2@uky.edu

859-323-4712

Other Identifiers

1R01NR020478-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

80203

Identifier Type: -

Identifier Source: org_study_id