Hypertension; Community Health WorkersCHW-HTCNCT05068505
Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda
A study testing Community health worker delivered multicomponent intervention in people with Hypertension; Community Health Workers, run by Charite University, Berlin, Germany at 1 site in Uganda.
Trial summary
Over 80% of the morbidity and mortality related to non-communicable diseases (NCDs) occurs in low-income and middle-income countries (LMICs). Community health workers (CHWs) may improve disease control and medication adherence among patients with NCDs in LMICs, but data are scarce, particularly in sub-Saharan African… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension; Community Health Workers
- What is being tested?
- Community health worker delivered multicomponent intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 869 participants
- Where
- 1 siteUganda
- Study dates
- 5 Jan 2023to 28 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with hypertension (Systolic >140 and/or Diastolic >90)
- Participants attending the two NCD clinics
- Adults 18 years and above
- Participants residing in the three sub counties (Nakaseke Town Council, Nakaseke Sub County and Kasangombe of Nakaseke district)
- Participants able to give informed consent.
Who cannot join
- Patients diagnosed with hypertension but already controlled
- Pregnant women
- Patients with an expected life expectancy of less than one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda: a Stepped Wedge, Cluster Randomized Control Trial
Over 80% of the morbidity and mortality related to non-communicable diseases (NCDs) occurs in low-income and middle-income countries (LMICs). Community health workers (CHWs) may improve disease control and medication adherence among patients with NCDs in LMICs, but data are scarce, particularly in sub-Saharan African settings. In Uganda, and the majority of LMICs, management of uncontrolled blood pressure remains limited in constrained health systems. Intervening at the primary care level, using CHWs to improve medical treatment outcomes has not been well studied. The investigators aim to determine the effectiveness of a CHW-led intervention in blood pressure control among confirmed hypertensive patients and patient-related factors associated with uncontrolled hypertension. Methods: Conduction of a stepped-wedge cluster randomized controlled trial study of 869 adult patients with hypertension attending two NCD clinics to test the effectiveness, acceptability and fidelity of a CHW-led intervention. The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of seven months, consisting of the following; (1) blood pressure and sugar monitoring; (2) BMI monitoring; (3) cardiovascular disease risk assessment; (4) Using checklists to guide monitoring and referral to clinics; (5) healthy lifestyle counselling and education. During home visits, CHWs will remind patients of follow-up visits. The investigators will measure blood pressure at baseline and 3-monthly for the entire cohort. The investigators will additionally test acceptability of the intervention and fidelity over the course of the intervention. The investigators will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community. Conclusion: The results of this study will inform community delivered hypertension management across a range of LMIC settings.
- Conditions
- Hypertension; Community Health Workers
- Being tested
- Community health worker delivered multicomponent intervention
- Keywords
- Hypertension, Community health workers, Uncontrolled blood pressure, Uganda
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community health worker delivered multicomponent interventionBehavioural
The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of seven months in a rural setting in Nakaseke, Uganda, consisting of the following; (1) blood pressure and sugar monitoring; (2) BMI monitoring; (3) cardiovascular disease risk assessment; (4) Using checklists to guide monitoring and referral to clinics; (5) healthy lifestyle counselling and education. During home visits, CHWs will remind patients of follow-up visits. We will measure blood pressure at baseline and 3-monthly for the entire cohort. We will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community.
We will conduct an interim analysis at 3 months to assess differences between groups. If a statistically significant difference is detected the intervention will be applied across the remaining clusters
| Study group | Role | What they receive |
|---|---|---|
| Community health worker delivered multicomponent intervention | Experimental | The study will employ a closed cohort stepped wedge cluster randomized design. There will be a sequential crossover of clusters from the control to the intervention arms and the order of the cross over will be randomly determined. This study will be conducted in 21 clusters within Nakaseke district. Each cluster will consist of 4-5 villages. We plan to rollout the intervention in three clusters per month. Receives: Behavioral: Community health worker delivered multicomponent intervention |
| Control | No intervention | All clusters will be observed under both the intervention and control arm through sequential crossover. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure control
Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms.
Measured: 3 months
Secondary outcomes (2)
Glycemic control
Defined as a reduction >1% in heamoglobin A1C
Measured: 3 months
Proportion of participants with blood pressure control
Defined as blood pressure <140/90 mmHg
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start5 Jan 2023
- Primary completion1 Feb 2024
- Study completion28 Feb 2024
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 Hypertension; Community Health WorkersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 869 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, Makerere University, Yale University, London School of Hygiene and Tropical Medicine, Johns Hopkins University, Ministry of Health, Uganda, African Community Center for Social Sustainability
- Responsible party
- Principal investigator, Prof. Dr. med. Felix Knauf, Charite University, Berlin, Germany
- Investigators
- Felix Knauf, Prof.Dr.med., Principal investigator, Charité University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068505
- Sponsor's protocol ID
- Balamu2021
- Acronym
- CHW-HTC
- Status last verified
- Feb 2024
- First submitted
- 15 Sep 2021
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ingenhoff R, Nandawula J, Siddharthan T, Ssekitoleko I, Munana R, Bodnar BE, Weswa I, Kirenga BJ, Mutungi G, van der Giet M, Kalyesubula R, Knauf F. Effectiveness of a community health worker-delivered care intervention for hypertension control in Uganda: study protocol for a stepped wedge, cluster randomized control trial. Trials. 2022 May 24;23(1):440. doi: 10.1186/s13063-022-06403-9.
PubMed 35610712
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Community Health Worker Delivered Care Intervention for Hypertension Control in Uganda: a Stepped Wedge, Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05068505
- Acronym / sponsor ID
- CHW-HTC / Balamu2021
- Conditions
- Hypertension; Community Health Workers
- Keywords
- Hypertension, Community health workers, Uncontrolled blood pressure, Uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 869 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- University of Miami, Makerere University, Yale University, London School of Hygiene and Tropical Medicine, Johns Hopkins University, Ministry of Health, Uganda, African Community Center for Social Sustainability
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 6 Oct 2021 (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.
Over 80% of the morbidity and mortality related to non-communicable diseases (NCDs) occurs in low-income and middle-income countries (LMICs). Community health workers (CHWs) may improve disease control and medication adherence among patients with NCDs in LMICs, but data are scarce, particularly in sub-Saharan African settings. In Uganda, and the majority of LMICs, management of uncontrolled blood pressure remains limited in constrained health systems. Intervening at the primary care level, using CHWs to improve medical treatment outcomes has not been well studied. The investigators aim to determine the effectiveness of a CHW-led intervention in blood pressure control among confirmed hypertensive patients and patient-related factors associated with uncontrolled hypertension. Methods: Conduction of a stepped-wedge cluster randomized controlled trial study of 869 adult patients with hypertension attending two NCD clinics to test the effectiveness, acceptability and fidelity of a CHW-led intervention. The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of seven months, consisting of the following; (1) blood pressure and sugar monitoring; (2) BMI monitoring; (3) cardiovascular disease risk assessment; (4) Using checklists to guide monitoring and referral to clinics; (5) healthy lifestyle counselling and education. During home visits, CHWs will remind patients of follow-up visits. The investigators will measure blood pressure at baseline and 3-monthly for the entire cohort. The investigators will additionally test acceptability of the intervention and fidelity over the course of the intervention. The investigators will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community. Conclusion: The results of this study will inform community delivered hypertension management across a range of LMIC settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community health worker delivered multicomponent intervention | Experimental | Behavioral: Community health worker delivered multicomponent interventionThe study will employ a closed cohort stepped wedge cluster randomized design. There will be a sequential crossover of clusters from the control to the intervention arms and the order of the cross over will be randomly determined. This study will be conducted in 21 clusters within Nakaseke district. Each cluster will consist of 4-5 villages. We plan to rollout the intervention in three clusters per month. |
| Control | No intervention | –All clusters will be observed under both the intervention and control arm through sequential crossover. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with hypertension (Systolic >140 and/or Diastolic >90)
- Participants attending the two NCD clinics
- Adults 18 years and above
- Participants residing in the three sub counties (Nakaseke Town Council, Nakaseke Sub County and Kasangombe of Nakaseke district)
- Participants able to give informed consent.
Key exclusion criteria (3 listed)
- Patients diagnosed with hypertension but already controlled
- Pregnant women
- Patients with an expected life expectancy of less than one year
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 |
|---|---|---|
| Community health worker delivered multicomponent interventionThe multi-component intervention will be centered on monthly household visits by trained CHWs for a period of seven months in a rural setting in Nakaseke, Uganda, consisting of the following; (1) blood pressure and sugar monitoring; (2) BMI monitoring; (3) cardiovascular disease risk assessment; (4) Using checklists to guide monitoring and referral to clinics; (5) healthy lifestyle counselling and education. During home visits, CHWs will remind patients of follow-up visits. We will measure blood pressure at baseline and 3-monthly for the entire cohort. We will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community. We will conduct an interim analysis at 3 months to assess differences between groups. If a statistically significant difference is detected the intervention will be applied across the remaining clusters | Behavioural | Community health worker delivered multicomponent intervention |
Primary outcome
Blood pressure control
Time frame: 3 months
Decrease in the average systolic and/or diastolic blood pressure between the intervention and control arms.
2 secondary outcomes
Glycemic control
Time frame: 3 months
Proportion of participants with blood pressure control
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Derived from this study: PubMed 35610712Ingenhoff R, Nandawula J, Siddharthan T, Ssekitoleko I, Munana R, Bodnar BE, Weswa I, Kirenga BJ, Mutungi G, van der Giet M, Kalyesubula R, Knauf F. Effectiveness of a community health worker-delivered care intervention for hypertension control in Uganda: study protocol for a stepped wedge, cluster randomized control trial. Trials. 2022 May 24;23(1):440. doi: 10.1186/s13063-022-06403-9.
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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. This study is not recruiting at the moment.
Felix Knauf, Prof.Dr.med. principal investigator
Charité University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community health worker delivered multicomponent intervention in people with Hypertension; Community Health Workers, run by Charite University, Berlin, Germany at 1 site in Uganda.
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 5 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: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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?
Blood pressure control (time frame: 3 months). 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 NCT05068505, 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 29 Feb 2024.