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Not yet recruiting NCT07412106

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

No phase Interventional Hypertension Self-Care Practices Medication Adherence Hospital Admission

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Telemedicine-Based Behavioral Counseling.
Who it may be relevant to
Registry conditions: Hypertension, Self-Care Practices, Medication Adherence, Hospital Admission. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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)

Detailed description

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

Interventions

  • Behavioral Telemedicine-Based Behavioral Counseling
    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 ne

Primary outcome measures

  • 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.]
Secondary outcome measures (3)
  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • WHO. Hypertension. World Health Organization; 2025.

Identifiers

NCT: NCT07412106 · Protocol Number: 6006/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗