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HypertensionADHINCRANCT04010344

Addressing Hypertension Care in Africa

A study of Hypertension and Diabetes, run by Johns Hopkins University at 4 sites in Ghana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A pilot cluster randomized control trial to test the feasibility of a multilevel, nurse-led, mobile health enhanced intervention in patients with uncontrolled hypertension in Ghana Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hypertension, Diabetes, Telemedicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
4 sitesGhana
Study dates
14 Jul 2019to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients will be included if they are 18-70 years old;
  • Male or female
  • Uncontrolled hypertension (SBP ≥140 mm Hg) based upon last outpatient encounter within the previous three months
  • Patients with previous strokes, coronary artery disease, up to stage three kidney disease and diabetes mellitus meeting BP cut-off criteria will be eligible for enrollment.

Who cannot join

  • Patients will be excluded if they fail to meet any of the above inclusion criteria
  • Severe cognitive impairment/dementia (Modified Mini-Mental State Examination (MMSE) score ≤24)
  • Severe global disability (modified Rankin Scale (mRS) score ≥3)
  • Not able to independently follow blood pressure measurement protocol or use of Smartphone for study protocol or without a care-giver to assist with BP monitoring at home
  • Patients with estimated glomerular filtration rate (eGFR) <30ml/min

Trial locations and contacts

4 sites in 1 country.

Ghana4 sites

  • Komfo Anokye Teaching Hospital

    Kumasi, Ashanti Region

  • Kumasi South Hospital

    Kumasi, Ashanti Region

  • Manhyia Government Hospital

    Kumasi, Ashanti Region

  • Suntreso Government Hospital

    Kumasi, Ashanti Region

Other trials in Ghana

About this study

Official title: Addressing Hypertension Control in Africa (ADHINCRA) Study

A pilot cluster randomized control trial to test the feasibility of a multilevel, nurse-led, mobile health enhanced intervention in patients with uncontrolled hypertension in Ghana

Read the detailed description

This is a two-arm pilot cluster randomized controlled trial (RCT) involving 240 participants with uncontrolled hypertension (HTN) with the healthcare setting as the unit of randomization and patients as the unit of analysis. Each of the four healthcare settings will be recruited and randomly assigned to the multilevel intervention or control group. A statistician will generate the randomization using a computer-generated random sequence program with an allocation ratio of 1:1 and a block size of 6 (to assure equal numbers in each arm). After having met study criteria for enrollment, 60 eligible patients for each setting will be assigned to either control or intervention arm according to the patients' healthcare setting's intervention assignment by the study coordinator. A cluster RCT has been chosen to avoid potential treatment contamination in which physicians within healthcare settings might unintentionally provide patients with different degrees of attention or blending of treatment protocols. The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.

The investigators will use quota sampling to over sample socioeconomically deprived persons to ensure that socioeconomically deprived persons comprise 50% of the sample. Poverty will be defined by (1) Household income, based on Ghana minimum monthly wage of 210 Ghana cedis (equivalent of $55). After screening eligible participants, the investigators will assign four clusters of 60 patients to the intervention or control arms. The investigators will require 30 patients in each cluster to be male and 30 to be female since in the investigators' previous work, men have been underrepresented potentially due to gender-differences in healthcare seeking behaviors. Men have also had inferior treatment and control rates in previous studies.

Being tested
Enhanced Usual Care Group, Usual Care Group
Medical subject headings
Hypertension, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Usual Care GroupBehavioural

    Medtronic® Labs' Akoma pa app, a culturally-tested and locally attuned mobile health platform, will be used in the intervention arm of the study to improve communication between the Community Health Officer (CHO) and the participant. This platform will be used to enhance shared decision making, clinical decision support, participatory communication, knowledge, treatment adherence (medication and lifestyle modification), and self-monitoring of hypertension. We will test the feasibility of the Akoma pa app in addressing patient-level and provider-level barriers to hypertension control.

    The app will consist of the following components:

    1. Reminders
    2. Participant to CHO messaging
    3. Home BP tracking
    4. Educational materials on cardiovascular disease (CVD) and Stroke- Participants will have access to education modules on reducing the risk of CVD and stroke tailored to their knowledge level.
    5. CHO provider portal- The provider portal will include decision support tools.

  • Usual Care GroupOther

    Regular/usual appointments or visits to patients' healthcare provider for management of study outcomes

Study groups in NCT04010344
Study groupRoleWhat they receive
Enhanced Usual Care GroupExperimentalAll participants in the enhanced usual care arm must own a cell phone with at least short message service (SMS) and voicemail. To control for attention exposure, they will receive SMS messages daily dealing with healthy lifestyle behaviors (smoking, diet, physical activity) but not with medication adherence or hypertension-specific issues. Every three days (comparable to intervention group monitoring) they will receive an automated SMS directing them to a different 2-3 min video/YouTube™ clips on healthy lifestyles. Patients in this arm of the study will also receive usual care as determined by their providers. Usual care is described in the next section.
Receives: Behavioral: Enhanced Usual Care Group
Usual CareActive comparatorPatients in this arm of the study will receive usual care as determined by their providers. Usual care in the region typically involves at least one visit every 2-3 months for review of adherence to treatment, blood pressure control, and prescriptions for medication refills. Similar to the intervention group, participants will have a total of three follow-up visits which will be separate from their regular appointments during which study outcomes will be assessed.
Receives: Other: Usual Care Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Blood Pressure levels from Baseline

    Changes in Blood pressure levels, measured in mmHg, will be assessed at the baseline, 1-month, 3-month, 6-month, 9-month, and 12-month visits.

    Measured: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

  2. Change in Blood Pressure control by poverty status from Baseline

    Blood pressure control - defined as systolic blood pressure (SBP) < 140 mm Hg SBP reduction will be compared by deprivation status defined by monthly income < 210 Ghana cedis determined at the enrollment visit.

    Measured: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

Secondary outcomes (6)

  1. Change in glycohemoglobin (A1C) between arms

    Hgb A1C in both study arms will be examined for change at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.

    Measured: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

  2. Difference in Hypertensive Urgencies and Emergencies between arms

    Difference in the number of emergency room visits (for hypertensive urgencies and/or emergencies) for both arms will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits. after the initial baseline assessment.

    Measured: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

  3. Difference in Cardiovascular Disease (CVD) Events between study arms

    Difference in the number of CVD events (such as strokes, coronary artery disease, heart failures, and deaths) for both arms will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.

    Measured: Baseline, 1 month , 3 months, 6 months, 9 months, 12 months

  4. Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale

    Self-Reported Medication Adherence will be assessed with the 9-item Hill-Bone Medication Adherence Scale and compared in both arms at months 6 and 12 by poverty status. The Hill-Bone has broad applicability in measuring medication adherence in patients with hypertension, diabetes, chronic obstructive pulmonary disease, stroke among others. Scores range from 9 - 36 with higher scores indicating poorer adherence to antihypertensive drug therapy.

    Measured: At 6 months

  5. Difference in treatment adherence as assessed by the Hill-Bone Medication Adherence Scale

    Self-Reported Medication Adherence will be assessed with the 9-item Hill-Bone Medication Adherence Scale and compared in both arms at months 6 and 12 by poverty status. The Hill-Bone has broad applicability in measuring medication adherence in patients with hypertension, diabetes, chronic obstructive pulmonary disease, stroke among others. Scores range from 9 - 36 with higher scores indicating poorer adherence to antihypertensive drug therapy.

    Measured: At 12 months

  6. Change in the acceptability and usability of the Akoma pa app score as assessed by the Marshfield System Usability Survey

    The acceptability and usability of the Akoma pa app will be assessed with the 16-item Marshfield System Usability Survey. Scores on this instrument range from 16 to 80 with higher scores indicating better usability. This will be examined at the 1-month, 3-month, 6-month, 9-month, and 12-month visits after the initial baseline assessment.

    Measured: At 1 month , 3 months, 6 months, 9 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2019
  2. Study start14 Jul 2019
  3. Primary completion3 May 2021
  4. Study completion30 Dec 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm pilot cluster randomized control trial involving 240 participants with uncontrolled hypertension. The healthcare setting is the unit of randomization and patients are the unit of analysis. Each of the four healthcare settings will be recruited and randomly assigned to the multilevel intervention or control group. Randomization will be performed using a computer-generated random sequence program with a 1:1 allocation and a block size of 6 (to assure equal numbers in each arm). After meeting the study criteria for enrollment, 60 eligible patients for each setting will be assigned to either control or intervention arm according to their healthcare setting's intervention assignment by the study coordinator. The intervention will be administered for six months following which it will be withdrawn, and patients will be followed for six more months to assess outcomes.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04010344
Sponsor's protocol ID
IRB00218586
Acronym
ADHINCRA
Status last verified
Jan 2025
First submitted
3 Jul 2019
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1.

    PubMed 15652604

  • Sarfo-Kantanka O, Sarfo FS, Oparebea Ansah E, Eghan B, Ayisi-Boateng NK, Acheamfour-Akowuah E. Secular Trends in Admissions and Mortality Rates from Diabetes Mellitus in the Central Belt of Ghana: A 31-Year Review. PLoS One. 2016 Nov 22;11(11):e0165905. doi: 10.1371/journal.pone.0165905. eCollection 2016.

    PubMed 27875539

  • Sarfo FS, Ovbiagele B, Gebregziabher M, Wahab K, Akinyemi R, Akpalu A, Akpa O, Obiako R, Owolabi L, Jenkins C, Owolabi M; SIREN. Stroke Among Young West Africans: Evidence From the SIREN (Stroke Investigative Research and Educational Network) Large Multisite Case-Control Study. Stroke. 2018 May;49(5):1116-1122. doi: 10.1161/STROKEAHA.118.020783. Epub 2018 Apr 4.

    PubMed 29618553

  • Staessen JA, Wang JG, Thijs L. Cardiovascular protection and blood pressure reduction: a meta-analysis. Lancet. 2001 Oct 20;358(9290):1305-15. doi: 10.1016/S0140-6736(01)06411-X.

    PubMed 11684211

  • Agyemang C, Nyaaba G, Beune E, Meeks K, Owusu-Dabo E, Addo J, Aikins AD, Mockenhaupt FP, Bahendeka S, Danquah I, Schulze MB, Galbete C, Spranger J, Agyei-Baffour P, Henneman P, Klipstein-Grobusch K, Adeyemo A, van Straalen J, Commodore-Mensah Y, Appiah LT, Smeeth L, Stronks K. Variations in hypertension awareness, treatment, and control among Ghanaian migrants living in Amsterdam, Berlin, London, and nonmigrant Ghanaians living in rural and urban Ghana - the RODAM study. J Hypertens. 2018 Jan;36(1):169-177. doi: 10.1097/HJH.0000000000001520.

    PubMed 28858173

  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available.

    PubMed 28122885

  • Sanuade OA, Awuah RB, Kushitor M. Hypertension awareness, treatment and control in Ghana: a cross-sectional study. Ethn Health. 2020 Jul;25(5):702-716. doi: 10.1080/13557858.2018.1439898. Epub 2018 Feb 15.

    PubMed 29448808

  • Sarfo FS, Mobula LM, Burnham G, Ansong D, Plange-Rhule J, Sarfo-Kantanka O, Ofori-Adjei D. Factors associated with uncontrolled blood pressure among Ghanaians: Evidence from a multicenter hospital-based study. PLoS One. 2018 Mar 19;13(3):e0193494. doi: 10.1371/journal.pone.0193494. eCollection 2018.

    PubMed 29554106

  • Commodore-Mensah Y, Samuel LJ, Dennison-Himmelfarb CR, Agyemang C. Hypertension and overweight/obesity in Ghanaians and Nigerians living in West Africa and industrialized countries: a systematic review. J Hypertens. 2014 Mar;32(3):464-72. doi: 10.1097/HJH.0000000000000061.

    PubMed 24445390

  • Stephenson J. Noncompliance may cause half of antihypertensive drug "failures". JAMA. 1999 Jul 28;282(4):313-4. doi: 10.1001/jama.282.4.313. No abstract available.

    PubMed 10432015

  • Kretchy IA, Owusu-Daaku FT, Danquah S. Locus of control and anti-hypertensive medication adherence in Ghana. Pan Afr Med J. 2014 Jan 18;17 Suppl 1(Suppl 1):13. doi: 10.11694/pamj.supp.2014.17.1.3433. eCollection 2014.

    PubMed 24624246

  • Ogedegbe G, Plange-Rhule J, Gyamfi J, Chaplin W, Ntim M, Apusiga K, Iwelunmor J, Awudzi KY, Quakyi KN, Mogaverro J, Khurshid K, Tayo B, Cooper R. Health insurance coverage with or without a nurse-led task shifting strategy for hypertension control: A pragmatic cluster randomized trial in Ghana. PLoS Med. 2018 May 1;15(5):e1002561. doi: 10.1371/journal.pmed.1002561. eCollection 2018 May.

    PubMed 29715303

  • Barry MJ, Edgman-Levitan S. Shared decision making--pinnacle of patient-centered care. N Engl J Med. 2012 Mar 1;366(9):780-1. doi: 10.1056/NEJMp1109283. No abstract available.

    PubMed 22375967

  • Bakken S, Grullon-Figueroa L, Izquierdo R, Lee NJ, Morin P, Palmas W, Teresi J, Weinstock RS, Shea S, Starren J; IDEATel Consortium. Development, validation, and use of English and Spanish versions of the telemedicine satisfaction and usefulness questionnaire. J Am Med Inform Assoc. 2006 Nov-Dec;13(6):660-7. doi: 10.1197/jamia.M2146. Epub 2006 Aug 23.

    PubMed 16929036

  • Demiris G, Speedie S, Finkelstein S. A questionnaire for the assessment of patients' impressions of the risks and benefits of home telecare. J Telemed Telecare. 2000;6(5):278-84. doi: 10.1258/1357633001935914.

    PubMed 11070589

Questions about this trial

What is this clinical trial studying?

A study of Hypertension and Diabetes, run by Johns Hopkins University at 4 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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, 1 month , 3 months, 6 months, 9 months, 12 months). The study lists 2 primary outcomes in all. 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 NCT04010344, which also lists 18 linked publications.

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 Jan 2025.

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