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NCT Number: NCT07412106

Telemedicine-Based Behavioral Intervention to Improve Self-Care Among Hypertensive Patients

The goal of this quasi-experimental clinical study is to learn whether a telemedicine-based behavioral intervention can improve self-care practices among adult patients with hypertension receiving care at teaching hospitals in Northwest Amhara.

The main questions it aims to answer are:

* Does a telemedicine-based intervention improve self-care practices among hypertensive patients? * Does the intervention improve medication adherence among hypertensive patients? * Does the intervention increase patients' knowledge about hypertension? * Does the intervention reduce emergency hospital admissions among hypertensive patients? We will compare patients who receive telemedicine-based counseling with patients who receive usual care to see if the intervention improves self-care, medication adherence, knowledge, and reduces emergency admissions.

Participants will:

* Receive 10-15-minute telephone counseling sessions every two weeks for three months (intervention group only) * Receive education on blood pressure monitoring, medication adherence, diet, physical activity, and stress management (intervention group only) * Continue routine hypertension care at the hospital (both groups)

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Health Behavior Hospital Admission Medication Adherence Patient Acceptance of Health Care Patient Compliance Self-Care Practices Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Background Hypertension is a major cause of premature death worldwide. An estimated 1.4 billion adults aged 30-79 years worldwide had hypertension in 2024; this represents 33% of the population in this age range. Two-thirds of adults aged 30-79 years who have hypertension live in low- and middle-income countries. Previous meta-analysis showed that the pooled prevalence of hypertension in Ethiopia was 21.81%. The Digital Health Interventions (DHIs) for telemedicine/telehealth reduced office BP compared with usual care. In the US, Systematic reviews and meta-analyses find that digital health interventions, especially home BP telemonitoring with clinician feedback and medication titration, lower SBP by approximately 3-6 mmHg compared to usual care at 6-12 months.

Randomized control trial conducted in Japan revealed that telemedicine-based intervention was determined to be safe in managing hypertension, and the intervention group demonstrated a reduction in systolic blood pressure of 9.2 mmHg, whereas the reduction in the usual care group was 5.4 mmHg.

A systematic review and meta-analysis conducted in China showed that the group that used app-based mHealth was associated with better Blood Pressure control than the usual intervention group. Digital health interventions may be effective for Blood Pressure control, changes in lifestyle behaviors, and improvements in medication adherence in low and middle-income countries.

Regular phone-based intervention can enhance blood pressure control and improve medication adherence. The integration of digital health interventions with clinical management is crucial for achieving optimal clinical effectiveness in blood pressure control, lifestyle behavior modification, and medication adherence. The effect of telemedicine-based interventions on hypertension management outcomes remains uncertain in Ethiopia. Therefore, this protocol describes a structured telemedicine-based counseling intervention aimed at improving blood pressure control and medication adherence among hypertensive patients through remote behavioral support.

Study Design and Setting: A two-arm quasi-experimental design with two parallel groups and 1:1 allocation will be employed to evaluate the effect of telemedicine-based intervention on the outcomes of patients with hypertension. The study setting will be two teaching hospitals in Northwest Amhara, specifically

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients ≥18 with hypertension who have follow-up for ≥6 months at the study settings
  • Have access to mobile or fixed telephones
  • Will stay for the study follow-up period

Exclusion criteria

  • Participants who have coexisting severe mental health illnesses
  • Severe hearing impairments
  • Pregnant will be excluded

Treatment and study plan

Telemedicine-Based Behavioral Counseling

Behavioral

The intervention arm will receive a telemedicine-based behavioral intervention, while the control arm will receive usual care. The intervention package will be designed based on existing literature and culturally accepted approach. Participants in the intervention group will receive weakly, 10-15 minutes telephone-based counseling sessions on the management of non-communicable diseases (NCDs) every 2 weeks for three-months.

The intervention package for hypertensive patients will focus on the necessity of regular blood pressure assessment and provide comprehensive education to empower hypertensive patients in managing their condition. This package will include scheduled phone calls with trained healthcare providers who will offer guidance on lifestyle modifications, self care practice including regular physical activity, adhering to prescribed medications, and managing stress.

Primary outcomes

  1. Self-care practice

    Time frame: The intervention will be delivered over a period of three months, with participants in the intervention group receiving 10-15 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.

    Self-care practice will be measured using the Hypertension Self-Care Activity Level Effects (H-SCALE) instrument, which assesses adherence across six domains: medication, diet, physical activity, smoking, weight management, and alcohol use. Behaviors are evaluated over the past seven days, except weight management, which uses a five-point Likert scale.

    Each domain will be scored per standardized H-SCALE criteria and classified as good or poor. Medication adherence is good if all doses are taken daily. Diet is good if recommended practices are followed ≥6 days/week. Physical activity is good if ≥30 minutes are performed ≥5 days/week. Smoking is good if no smoking occurs. Weight management is good if the mean Likert score is ≥4. Alcohol use is good if consumed ≤1 day/week.

    A composite score sums the domains with good self-care. Participants achieving good self-care in ≥70% of domains will be classified as having overall good self-care practice.

Secondary outcomes

  1. Medication adherence

    Time frame: The intervention will be delivered over a period of three months, with participants in the intervention group receiving 10-15 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.

    Medication adherence will be measured using the Hill-Bone Medication Adherence Scale, which assesses behaviors related to taking prescribed blood pressure medications. The scale evaluates the frequency of missed doses, timing adherence, and correct dosing over the past seven days. Scores are calculated according to standardized Hill-Bone criteria, with higher scores indicating better adherence. Medication adherence will be classified as good if all prescribed doses are taken on all seven days, and poor if any dose is missed.

  2. Knowledge about hypertension life style management

    Time frame: The intervention will be delivered over a period of three months, with participants in the intervention group receiving 10-15 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.

    Knowledge about hypertension lifestyle management will be measured using the Hypertension Evaluation of Lifestyle and Management (HELM) scale. The HELM assesses patient knowledge across domains including diet, physical activity, weight control, smoking, alcohol use, and medication adherence. Items are scored according to standardized HELM criteria, with higher scores indicating better knowledge. Knowledge will be classified as good if the participant correctly answers ≥70% of items, and poor if <70% are answered correctly.

  3. Hospital admission

    Time frame: The intervention will be delivered over a period of three months, with participants in the intervention group receiving 10-15 minute telephone counseling sessions every two weeks. Assessments will be done at baseline and end of intervention.

    Hospital admission due to hypertension will be assessed using a self-report question: "Have you been admitted to a hospital in the past one month due to hypertension?" Responses are coded as 1 = Yes and 2 = No. This outcome will be analyzed as a binary variable, with "Yes" indicating an admission and "No" indicating no admission. The measure will be collected at baseline and at the end of the intervention period to evaluate recent hospitalization related to hypertension.

Study contacts

Contact information is provided by the study sponsor or research team.

Destaw E Abebaw, Master of Science (Msc)

CONTACT

[email protected]

+251918281262

Eyob K Bogale, Master of Public Health

CONTACT

[email protected]

+251961640637

Sponsors and collaborators

Lead sponsor

Bahir Dar University

Other

Registry information

Official study title

Effectiveness of a Telemedicine-Based Behavioral Intervention for Improving Self-Care Practice and Management Outcomes Among Hypertensive Patients Attending Tertiary Hospitals in Northwest Amhara: A Quasi-Experimental Study Intervention Protocol

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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