Telemedicine-Based Behavioral Intervention to Improve Self-Care Among Hypertensive Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBahir Dar University
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Participants who have coexisting severe mental health illnesses
Severe hearing impairments
Pregnant will be excluded
Trial design
Design model
Parallel
Treatments tested in this trial
Telemedicine-Based Behavioral Counseling
BehavioralThe 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.
Treatment groups
320 Participants
are divided into 2 treatment groupsGroup A: Telemedicine-Based Behavioral Intervention ArmExperimental treatment 1 intervention
Group B: Usual Care Control ArmNo intervention 0 interventions
Trial outcomes
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.
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 outcomes
1
Medication adherence
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.
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.2
Knowledge about hypertension life style management
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.
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.3
Hospital admission
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.
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.Locations
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Source ClinicalTrials.gov
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