Testing Feasibility of Medication Adherence Problem Solving for Hypertension

NCT05630521 | Completed

• 1 other identifier: 22031803
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Adherence to medications for high blood pressure is key to improving blood pressure control and reducing the impact of cardiovascular disease. This project will test the feasibility of a tailored telehealth intervention to help patients improve adherence to blood pressure medication.

Conditions

Hypertension; Adherence, Medication

Keywords

Medication adherence; Hypertension; Telehealth

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  Number of patients enrolled in the study divided by number of patients invited to participate

  12 weeks

• Participant engagement

  The number of intervention telehealth appointments kept divided by the number scheduled per-protocol

  12 weeks

• Patient satisfaction with intervention

  Qualitative responses to questions about intervention delivery and content

  12 weeks

• Participant retention

  % of randomized participants who complete the study

  12 weeks

Secondary Outcomes (2)

• Antihypertensive medication adherence

  12 weeks

• Blood pressure

  12 weeks

Study Arms (2)

Telehealth Intervention Group

EXPERIMENTAL

The intervention components are: 1) educational modules and 2) bi-weekly telehealth visits for managed problem solving for 12 weeks. All intervention participants will be provided four educational modules, electronically and in print form. The modules are adapted from evidence-based materials developed by the American Heart Association, American College of Cardiology, and Centers for Disease Control and Prevention and cover (1) the causes of HTN, (2) how HTN raises risks for other chronic conditions, (3) medications for effectively managing high BP, and (4) how to manage barriers to medication adherence. Telehealth visits will supplement and reinforce the educational modules, addressing participants' specific knowledge needs and enhancing self-efficacy.

Behavioral: Medication Adherence Problem Solving for Hypertension

Control

NO INTERVENTION

The study will use a usual-care control group. The standard of care for this patient population does not involve any type of medication adherence intervention or monitoring beyond regular clinic follow-up visits with their health care provider. Control group participants will be given printed handouts on the American Heart Association's Life's Simple 7 lifestyle changes for reducing cardiovascular risk, along with the instructions for using the MEMS cap. If control group participants ask about their antihypertensive medications during the study, they will be referred to their prescribing provider or pharmacist for any information that could not be obtained from the medication label or pharmacy packaging.

Interventions

Medication Adherence Problem Solving for Hypertension BEHAVIORAL

The MASH program is a 12-week intervention containing two components: (1) four education modules on HTN causes, risks, treatment, and barriers to treatment; and (2) telehealth visits every 2 weeks with a registered nurse to deliver evidence-based managed problem solving strategies tailored on patients' responses to assessments of HTN beliefs, medication beliefs, and barriers impacting their medication adherence.

Telehealth Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years at time of study entry
• Able to read, write, and converse in English
• Have an active prescription for at least one HTN medication, reporting no antihypertensive prescription changes for 30 days prior to study entry
• Have prescription drug coverage or participate in a prescription assistance program that covers medication costs.
• Diagnosis of HTN, based on self-report or confirmed through medical records, where available. (Self-reported high BP has long been shown to be strongly correlated with presence of a HTN diagnosis.22-24 Self-report combined with presence of a prescribed HTN medication ensures that only participants with HTN will be included)
• Must self-administer their own medications
• Uncontrolled BP: systolic (SBP) ≥ 130 mmHg and/or diastolic (DBP) ≥ 80 mmHg at baseline
• Nonadherent to HTN medication (Hill-Bone Medication Subscale score \< 36) at screening

You may not qualify if:

• Acutely ill (e.g., symptoms of myocardial infarction, respiratory distress, stroke)
• Patients who have end-stage renal disease (ESRD) and/or are on dialysis
• In state of hypertensive crisis (SBP \>180 and/or DBP \> 120 mmHg) at the time of study screening. Any participant in hypertensive crisis will be referred to their health care provider immediately for further instruction and follow-up, per current guidelines2
• BP measurement is contraindicated on both upper extremities
• Terminal chronic illness with a life expectancy of 6 months or less

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Todd Ruppar, PhD, RN

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study staff will be blinded to the randomization sequence. Due to the nature of the intervention, participants and investigators delivering the intervention cannot be blinded. Study staff collecting outcome data will be blinded to participant group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 29, 2022
• Study Start: February 20, 2023
• Primary Completion: August 25, 2024
• Study Completion: September 25, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available for other investigators once any of the primary study investigators' manuscripts using the data are accepted for publication. Duration of availability to be determined.
• Access Criteria: Requests for data will require a data-sharing agreement outlining the specific uses of the data.

Locations

US (1)