Medication AdherenceFamLit_HFNCT05548413
Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies
A study testing FamLit in people with Medication Adherence and Heart Failure, run by Jia-Rong Wu at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, Heart Failure
- What is being tested?
- FamLit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Jia-Rong Wu
Lexington, Kentucky, 40536
Jia-Rong Wu, PhD, 859-323-4712, jiarong.wu2@uky.edu
About this study
Official title: Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies in Patients With Heart Failure
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.
Read the 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
- Being tested
- FamLit, Attention Control
- Keywords
- care partner, family, health literacy, teach back
- Medical subject headings
- Medication Adherence, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FamLitBehavioural
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 ControlBehavioural
Participants in this group will talk with an interventionist to discuss general health. This intervention also includes use of the SimpleMed+ electronic pillbox.
| Study group | Role | What they receive |
|---|---|---|
| Patients - Attention Only | Active comparator | Patients with a confirmed diagnosis of heart failure. Receives: Behavioral: Attention Control |
| Care Partners - Attention Only | Active comparator | Care partners of patients with a confirmed diagnosis of heart failure. Receives: Behavioral: Attention Control |
| Patients - FamLit | Experimental | Patients with a confirmed diagnosis of heart failure. Receives: Behavioral: FamLit |
| Care Partners - FamLit | Experimental | Care partners of patients with a confirmed diagnosis of heart failure. Receives: Behavioral: FamLit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start4 Jan 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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
- 328 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jia-Rong Wu
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor-investigator, Jia-Rong Wu, The University of Tennessee, Knoxville
- Investigators
- Jia-Rong Wu, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548413
- Sponsor's protocol ID
- 80203
- Other IDs
- 1R01NR020478-01
- Acronym
- FamLit_HF
- Status last verified
- Apr 2026
- First submitted
- 16 Sep 2022
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Adherence Using Family-focused and Literacy-sensitive Strategies in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT05548413
- Acronym / sponsor ID
- FamLit_HF / 80203
- Conditions
- Medication Adherence, Heart Failure
- Keywords
- care partner, family, health literacy, teach back
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- Jia-Rong WuUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients - Attention Only | Active comparator | Behavioral: Attention ControlPatients with a confirmed diagnosis of heart failure. |
| Care Partners - Attention Only | Active comparator | Behavioral: Attention ControlCare partners of patients with a confirmed diagnosis of heart failure. |
| Patients - FamLit | Experimental | Behavioral: FamLitPatients with a confirmed diagnosis of heart failure. |
| Care Partners - FamLit | Experimental | Behavioral: FamLitCare partners of patients with a confirmed diagnosis of heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| FamLitThe 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. | Behavioural | Care Partners - FamLit, Patients - FamLit |
| Attention ControlParticipants in this group will talk with an interventionist to discuss general health. This intervention also includes use of the SimpleMed+ electronic pillbox. | Behavioural | Care Partners - Attention Only, Patients - Attention Only |
Primary outcome
Medication adherence
Time frame: 12 months
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%.
Self-reported medication adherence.
Time frame: 12 months
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.
3 secondary outcomes
Patient hospitalization
Time frame: 12 months
Quality of life - Minnesota Living with Heart Failure
Time frame: 12 months
Positive Affect
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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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.
Jia-Rong Wu principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FamLit in people with Medication Adherence and Heart Failure, run by Jia-Rong Wu 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia-Rong Wu, PhD (8593234712, jiarong.wu2@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence (time frame: 12 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 5 May 2026.