HypertensionAHOMKANCT06985199
Culturally-adapted Mobile Health Intervention for Hypertension Care
A study of Hypertension, run by Tufts University at 2 sites in Ghana.
Trial summary
A single-arm study to assess the ability of the AHOMKA platform for hypertension management to affect blood pressure change among urban and rural patients in Ghana. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesGhana
- Study dates
- 31 Oct 2024to 30 Sep 2025
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of hypertension
Who cannot join
- Comorbidities
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ghana2 sites
National Cardiothoracic Center
Accra, Ghana
Cardiothoracic Center - Outpatient Department
Ho, Ghana
About this study
Official title: AHOMKA Qualitative Study For Adaptation of the Medtronic Empower Health Platform
A single-arm study to assess the ability of the AHOMKA platform for hypertension management to affect blood pressure change among urban and rural patients in Ghana.
- Conditions
- Hypertension
- Being tested
- Enhanced Usual Care Group
- Keywords
- hypertension, mobile health
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual Care GroupBehavioural
A culturally-adapted mobile health platform will be used in the intervention to enable participants to record blood pressure and heart rate readings at home and store data in the mobile platform. Providers will have access to the store data using a provider-facing app.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care Group | Experimental | Participants with uncontrolled hypertension and the owner of a cell phone are selected. Participants will receive usual care as determined by their provider. Receives: Behavioral: Enhanced Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Pressure levels from Baseline
Changes in blood pressure levels, measured in mmHg, will be assessed at the baseline and 6-month endline visit.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start31 Oct 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study of mobile health application
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghana Medical School, Beth Israel Deaconess Medical Center, University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Valencia Koomson, Principal investigator, Tufts UniversityMark Tettey, MD, Principal investigator, University of Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985199
- Sponsor's protocol ID
- STUDY00001929
- Acronym
- AHOMKA
- Status last verified
- Jul 2025
- First submitted
- 14 May 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AHOMKA Qualitative Study For Adaptation of the Medtronic Empower Health Platform
- ClinicalTrials.gov ID
- NCT06985199
- Acronym / sponsor ID
- AHOMKA / STUDY00001929
- Conditions
- Hypertension
- Keywords
- hypertension, mobile health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- University of Ghana Medical School, Beth Israel Deaconess Medical Center, University of Health and Allied Sciences
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 22 May 2025 (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.
A single-arm study to assess the ability of the AHOMKA platform for hypertension management to affect blood pressure change among urban and rural patients in Ghana.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study of mobile health application
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care Group | Experimental | Behavioral: Enhanced Usual Care GroupParticipants with uncontrolled hypertension and the owner of a cell phone are selected. Participants will receive usual care as determined by their provider. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of hypertension
Key exclusion criteria (1 listed)
- Comorbidities
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 |
|---|---|---|
| Enhanced Usual Care GroupA culturally-adapted mobile health platform will be used in the intervention to enable participants to record blood pressure and heart rate readings at home and store data in the mobile platform. Providers will have access to the store data using a provider-facing app. | Behavioural | Enhanced Usual Care Group |
Primary outcome
Change in Blood Pressure levels from Baseline
Time frame: Baseline, 6 months
Changes in blood pressure levels, measured in mmHg, will be assessed at the baseline and 6-month endline visit.
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 18 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Valencia Koomson principal investigator
Tufts University
Mark Tettey, MD principal investigator
University of Ghana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hypertension, run by Tufts University at 2 sites in Ghana.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure levels from Baseline (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2025.