NCT06985199

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

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 Start

First participant enrolled

October 31, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

May 14, 2025

Last Update Submit

July 15, 2025

Conditions

Hypertension

Keywords

hypertension, mobile health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 6 months

Study Arms (1)

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.

Behavioral: Enhanced Usual Care Group

Interventions

Enhanced Usual Care GroupBEHAVIORAL

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.

Enhanced Usual Care Group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of hypertension

You may not qualify if:

  • Comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cardiothoracic Center

Accra, Ghana, Ghana

Location

Cardiothoracic Center - Outpatient Department

Ho, Ghana, Ghana

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Valencia Koomson

    Tufts University

    PRINCIPAL INVESTIGATOR

  • Mark Tettey, MD

    University of Ghana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Feasibility study of mobile health application
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 22, 2025

Study Start

October 31, 2024

Primary Completion

July 31, 2025

Study Completion

September 30, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

GH(2)