HypertensionNCT07412106
Telemedicine-Based Behavioral Intervention to Improve Self-Care Among Hypertensive Patients
A study testing Telemedicine-Based Behavioral Counseling in people with Hypertension and Self-Care Practices, run by Bahir Dar University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Self-Care Practices, Medication Adherence
- What is being tested?
- Telemedicine-Based Behavioral Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2026to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who have coexisting severe mental health illnesses
- Severe hearing impairments
- Pregnant will be excluded
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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:
Read more
- 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)
Read the 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
- Being tested
- Telemedicine-Based Behavioral Counseling
- Keywords
- Self-care practice, Medication adherence, Knowledge about hypertension, Emergency admission, Quasi experimental study, Hypertension
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-Based Behavioral CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion10 Mar 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahir Dar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eyob Ketema Bogale, Bahir Dar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412106
- Sponsor's protocol ID
- Protocol Number: 6006/2026
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
WHO. Hypertension. World Health Organization; 2025.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07412106
- Acronym / sponsor ID
- Protocol Number: 6006/2026
- Keywords
- Self-care practice, Medication adherence, Knowledge about hypertension, Emergency admission, Quasi experimental study, Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Bahir Dar UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Telemedicine-Based Behavioral Intervention Arm | Experimental | Behavioral: Telemedicine-Based Behavioral CounselingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Participants who have coexisting severe mental health illnesses
- Severe hearing impairments
- Pregnant will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-Based Behavioral CounselingThe 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. | Behavioural | Telemedicine-Based Behavioral Intervention Arm |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Results publicationWHO. Hypertension. World Health Organization; 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine-Based Behavioral Counseling in people with Hypertension and Self-Care Practices, run by Bahir Dar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eyob K Bogale, Master of Public Health (+251961640637, ketema.eyob@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07412106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.