Effectiveness of Phone Call and Video-based Interventions to Improve Adherence to Medications in Hypertensive Patients

NCT06927271 | Recruiting

• 1 other identifier: GHS-ERC:001/10/23
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find out if phone call and video-based interventions that seek to educate people with uncontrolled high blood pressure and also remind them to take their medicines will improve adherence to their medicines. It will also examine if the interventions are economical to implement. The main objectives of the study are:

• Design videos and phone call-based interventions for people with hypertension.
• Examine the effect of videos and phone call-based intervention on adherence to medication in people with hypertension.
• Calculate the costs associated with the mobile health intervention
• Examine the factors influencing acceptance of video and phone calls based interventions for improving adherence to antihypertensive medications among patients Participants will:
• Receive the intervention thrice weekly for 3 months
• Visit the health facility at the end of 3 months for check up and measurement of outcome variables (adherence and blood pressure). Additionally, at the end of 3 months, the acceptability of the interventions will be measured among the participants who received either phone call or video. Researchers will compare the two groups (one group will utilize phone call whereas the other videos) with the control group to see if the mobile interventions improve adherence to medicines. Only adults 18 years and above in selected health facilities in the Eastern will participate in the study. The selected participants should have uncontrolled blood pressure based on readings from last 2 visits. To be included in the study, the participants need to own a smartphone.

Conditions

Hypertension; Hypertension (Without Type 2 Diabetes Mellitus)

Keywords

hypertension; adherence; medications; mHealth; mobile technology

Outcome Measures

Primary Outcomes (2)

• change in systolic blood pressure

  The systolic blood pressure at baseline will be compared to the systolic pressure at endline. This will help to determine if the intervention has an effect on the blood pressure

  baseline and 3 months

• Medication adherence measured using the Morisky Medication Adherence Scale-8(MMAS-8)

  Medication adherence will be measured at baseline and then after administering the intervention. MMAS-8 has eight items on the scale. The first seven (7) items on the scale require a yes or no response whereas the eighth item uses a five-point Likert scale (never/rarely to all the time). The total score ranges from 0 to 8 with a score of \<6 indicative of non-adherence. A score between 6 \< 8 indicates medium adherence whereas a score of 8 shows high adherence.

  baseline and 3 months

Secondary Outcomes (2)

• Proportion of patients with controlled blood pressure

  baseline and 3 months

• Acceptability of the intervention

  3 months

Study Arms (3)

the video-group

ACTIVE COMPARATOR

In this arm, participants with uncontrolled blood pressure will receive videos via WhatsApp to educate them about the condition hypertension, side effects of medications and also remind them to take their medications. The intervention will be administered on days and time convenient for the patient and will be administered thrice weekly for 3 months. Participants in this group will receive the video intervention in addition to usual care (which is the care they receive from health facilities)

Other: Video based intervention

the phone call group

ACTIVE COMPARATOR

In this arm, participants with uncontrolled blood pressure will receive phone calls to educate them about the condition hypertension, side effects of medications and also remind them to take their medications. The intervention will be administered on days and time convenient for the patient and will be administered thrice weekly for 3 months. Participants in this group will receive the phone call intervention in addition to usual care (which is the care they receive from health facilities)

Other: phone call based intervention

control group

PLACEBO COMPARATOR

This group will neither receive phone call or videos. The group will only receive a message that indicates that they are being enrolled into the study.

Other: Usual Care

Interventions

phone call based intervention OTHER

The phone call based intervention seek to educate patients about hypertension and the medications used. It also seeks to remind patients to take their medications. This will be done thrice weekly

the phone call group

Video based intervention OTHER

The video based intervention seek to educate patients about hypertension and the medications used. It also seeks to remind patients to take their medications. This will be done thrice weekly

the video-group

Usual Care OTHER

The usual care concerns the care the participants receive from the health facility. Participants in this group would neither receive the phonecall or video based interventions.

control group

Eligibility Criteria

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

You may qualify if:

• adult aged 18 years or older
• diagnosed of hypertension
• has uncontrolled hypertension (i.e. systolic blood pressure ≥140 mmHg and a diastolic blood pressure ≥ 90mmHg) documented in their records on 2 clinic visits
• has been prescribed at least one antihypertensive medication for a period of 2 months before the study
• owns a smart phone or has access to one at all times.

You may not qualify if:

• Pregnant women with hypertension or within 3 months postpartum
• Hypertensive patients with diabetes, liver failure or kidney disease
• Plans to travel out of the country during the period of the study
• Participating in another mobile health intervention or medication adherence intervention
• has a psychiatric disease or mental illness 6) has a visual impairment.

Sponsors & Collaborators

• University of Ghana: lead

Study Sites (1)

St Joseph Catholic Hospital

Efiduase, Koforidua, Ghana

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Patrick Asuming, PhD

  University of Ghana

  STUDY DIRECTOR

• Gordon Abekah-Nkrumah, PhD

  University of Ghana

  STUDY CHAIR

Central Study Contacts

Grace Okai, MPhil

CONTACT

+233242889013; graforiwaa@yahoo.com

Gordon Abekah-Nkrumah, PhD

CONTACT

+233553122132; gabekah-nkrumah@ug.edu.gh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: April 15, 2025
• Study Start: February 24, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be available
• Access Criteria: The study protocol will be available online to all. The study protocol will be shared through publications.

Locations

GH (1)