NCT07412106

Brief Summary

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)

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
1mo left

Started Feb 2026

Shorter than P25 for not_applicable hypertension

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

January 31, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Expected
Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

28 days

First QC Date

January 31, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

Self-care practiceMedication adherenceKnowledge about hypertensionEmergency admissionQuasi experimental studyHypertension

Outcome Measures

Primary Outcomes (1)

  • Self-care practice

    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.

    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.

Secondary Outcomes (3)

  • Medication adherence

    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 life style management

    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

    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.

Study Arms (2)

Telemedicine-Based Behavioral Intervention Arm

EXPERIMENTAL

The intervention arm will receive a telemedicine-based behavioral intervention, including 10-15 minutes phone counseling sessions every 2 weeks for three months. Trained healthcare providers will educate patients on blood pressure monitoring, medication adherence, healthy diet, physical activity, stress management, and warning signs of complications. The intervention is designed based on literature and culturally appropriate practices. The control group will receive usual care without tailored support.

Behavioral: Telemedicine-Based Behavioral Counseling

Usual Care Control Arm

NO INTERVENTION

The control arm will receive standard hypertension care provided at the hospitals, which may include routine clinical visits, prescribed medications, and general health advice, but will not include the telemedicine-based counseling or tailored self-care support provided to the intervention group.

Interventions

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.

Telemedicine-Based Behavioral Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • WHO. Hypertension. World Health Organization; 2025.

    RESULT

MeSH Terms

Conditions

HypertensionMedication Adherence

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Eyob K Bogale, Master of Public Health

CONTACT

Destaw E Abebaw, Master of Science (Msc)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking Description
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Model Description
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 17, 2026

Study Start

February 10, 2026

Primary Completion

March 10, 2026

Study Completion (Estimated)

July 10, 2026

Last Updated

February 17, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to confidentiality and privacy concerns, as the dataset contains sensitive health information. Sharing is restricted by ethical approvals and participant consent limitations.