HypertensionPhase 3STRENGTHSNCT03543787
Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS)
A Phase 3 study testing Health IT and Peer Support Intervention in people with Hypertension, run by Moi University at 1 site in Kenya.
Trial summary
"STRENGTHS" is a transdisciplinary implementation research study, guided by the PRECEDE-PROCEED framework, to address the challenge of improving hypertension control in low-resource settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Health IT and Peer Support Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteKenya
- Study dates
- 17 Jan 2020to 31 May 2023
- Phase
- Phase 3
- 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
- >= 18 yrs
- Enrolled in AMPATH CDM Program
- meet criteria for referral up or down the network
- Patients with complicated hypertension meet criteria for referral up the network, defined as patients with hypertension who remain uncontrolled (SBP >= 140 or DBP >= 90) on 3 or more anti-hypertensive medications, who have signs or symptoms of end-organ damage, or who have suspected secondary causes of hypertension (age <35 years, HIV, or pregnancy)
- Patients with stable, uncomplicated hypertension meet criteria for referral down the network, defined as controlled BP (SBP < 140 and DBP < 90) for 3 or more consecutive visits and no evidence of new end-organ damage
Who cannot join
- acute illness requiring immediate medical attention
- terminal illness
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
"STRENGTHS" is a transdisciplinary implementation research study, guided by the PRECEDE-PROCEED framework, to address the challenge of improving hypertension control in low-resource settings. The investigators propose to test the hypothesis that referral networks strengthened by an integrated health information technology and peer support intervention will be effective and cost-effective in improving hypertension control among patients in western Kenya. The investigators hypothesise that the integrated Health information Technology and Peer Support intervention will facilitate seamless referral of hypertensive patients across the different levels of the health system compared to usual care, leading to improvement in blood pressure. If proven to be successful, STRENGTHS can serve as a model for improving referral of patients upstream and downstream in health systems worldwide.
Read the detailed description
Hypertension is a major risk factor for cardiovascular disease, and 80% of global mortality due to cardiovascular diseases occurs in low- and middle-income countries. In low income countries, lack of coordination between different levels of the health system threatens the ability to provide the care necessary to control hypertension and prevent cardiovascular disease related morbidity. Strong referral networks have improved health outcomes for chronic disease in a variety of settings. Health information technology and peer-based support are two strategies that have improved care coordination and clinical outcomes. However, their effectiveness in strengthening referral networks to improve blood pressure control and reduce cardiovascular disease risk in low-resource settings is unknown.
The Academic Model Providing Access to Healthcare (AMPATH) partners with the Kenya Ministry of Health to provide care for non-communicable chronic diseases (NCDs), including hypertension at all levels of the health system. The Kenya Ministry of Health Sector Referral Strategy 2014-2018 calls for improving the referral system at every level of the health system. AMPATH has piloted both health information technology and peer support for NCDs, and both strategies are feasible in this setting. However, the impact of integrating Health information technology and peer support to strengthen referral networks for hypertension control is unknown.
The proposal's objective is to utilise the PRECEDE-PROCEED framework to conduct trans-disciplinary, translational implementation research focused on strengthening referral networks for hypertension control. The central hypothesis is "Health Information Technology integrated with peer support will be effective and cost-effective in strengthening referral networks, improving blood pressure control, and reducing cardiovascular risk among hypertensive patients in western Kenya." The investigators hypothesise that Health information technology(HIT) and peer support(PS) will synergistically address barriers to hypertension control at the patient, provider and health system levels. The investigators further hypothesise that changes in referral network characteristics may mediate the impact of the intervention on the primary outcome, and that baseline referral net-work characteristics may moderate the impact of the intervention. To test these hypotheses and achieve the overall objective, STRENGTHS has the following specific aims:
Aim 1: Conduct a baseline needs and contextual assessment for implementing and integrating HIT and PS to strengthen referral networks for hypertension control, using a mixed-methods approach, including: observational process mapping and gap assessment; baseline referral network analysis; and qualitative methods to identify facilitators, barriers, contextual factors, and readiness for change.
Sub-Aim 1.1: Use data from the aim 1 to develop a contextually and culturally appropriate intervention to strengthen referral networks for hypertension control using a participatory, iterative design process. Conduct pilot acceptability and feasibility testing of the intervention.
Aim 2: Evaluate the effectiveness of HIT and PS for hypertension control by conducting a two-arm cluster randomized trial comparing: 1) usual care vs. 2) referral networks strengthened with an integrated HIT-PS intervention. The primary outcome will be one-year change in systolic blood pressure and a key secondary outcome will be cardiovascular risk reduction.
Sub-Aim 2.1: Conduct mediation analysis to evaluate the influence of changes in referral network characteristics on intervention outcomes, and a moderation analysis to evaluate the influence of baseline referral net-work characteristics on the effectiveness of the intervention.
Sub-Aim 2.2: Conduct a process evaluation using the Saunders framework, evaluating key implementation measures related to fidelity, dose delivered, dose received, recruitment, reach, and context.
Aim 3: Evaluate the incremental cost-effectiveness of the intervention, in terms of costs per unit decrease in SBP, per percent change in CVD risk score, and per disability-adjusted life year (DALY) saved.
This research project will add to the existing knowledge base on innovative and scalable strategies for strengthening referral networks to improve control of NCDs in lower-MICs. If proven to be effective, it has the potential to be a scalable model for other low-resource settings globally.
- Conditions
- Hypertension
- Being tested
- Health IT and Peer Support Intervention
- Keywords
- Referral networks, low and middle income countries, PRECEDE-PROCEED, implementation research, hypertension, cardiovascular disease, process evaluation
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health IT and Peer Support InterventionCombination product
Health IT will support referral system by establishing 1) communication between healthcare providers and peer navigators 2) decision support for clinician to facilitate appropriate referrals 3) tracking of referred patients real-time 4) dashboards to monitor key evaluation metrics.
Peer Support intervention: peer navigators at each level of the referral network will ensure 1) referral adherence by link clinicians and patients 2) health system navigation 3) psychosocial support: leverage their shared disease experience to help patients overcome barriers to health seeking behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Health IT and Peer Support Intervention | Active comparator | Utilise electronic decision support, tracking of referral list and Peer facilitation for referral completion Receives: Combination Product: Health IT and Peer Support Intervention |
| Non intervention group | No intervention | 2014 - 2018 MoH referral protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in one year systolic blood pressure as measured in clinic
The systolic blood pressure at baseline will be compared to systolic blood after 1 year of follow up. Blood pressure measurements will be averaged from three successive readings taken every 5 minutes in clinic
Measured: 1 year
Secondary outcomes (6)
Change in one year overall Cardiovascular disease (CVD) QRISK2 score
QRISK2 score is a computerised algorithm for predicting the ten-year risk of developing CVD events. The factors that enter into the calculation of the QRISK2 score include: Age 25-84 years, sex, ethnicity, smoking status, diabetes status, family history of coronary artery disease in first degree relatives below the age of 65 years, chronic kidney disease stages 4 and 5, atrial fibrillation, rheumatoid arthritis, cholesterol / high density lipoprotein ratio, systolic blood pressure, body mass index. A score of 10% or more suggest a 10% risk of primary CVD events in ten years and warrants intervention to reduce the risk. It's not used among patients who already have a heart attack or a stroke.
Measured: 1 year
Mortality
Death at the end of the study
Measured: 1 year follow up
Hospitalisation
Number of self-reported hospital admissions for hypertensive crises or heart failure among participants over one year follow up.
Measured: 1 year of follow up
Cardiovascular disease complications
Any cardiovascular complications including Heart failure, Stroke and Acute myocardial infarction
Measured: 1 year follow up
Change in number of CVD risk factors and behaviors as assessed using a standardised screening questionnaire
Baseline risk factor profile compared to profile at 1 year of the various CVD risk factors as assessed using a standardised CVD risk factors and behaviours screening questionnaire
Measured: 1 year
Self reported adherence to hypertension medication as assessed using the Morisky Medication adherence questionnaire
To assess changes in adherence to hypertension medications at one year from baseline as determined using the Morisky medication adherence questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start17 Jan 2020
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- PRECEDE-PROCEED implementation research framework; 2-arm cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moi University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Duke University, Icahn School of Medicine at Mount Sinai, Purdue University, University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Constantine O Akwanalo, Principal investigator, Moi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543787
- Sponsor's protocol ID
- 1U01HL138636-01
- Acronym
- STRENGTHS
- Status last verified
- Mar 2023
- First submitted
- 19 Dec 2017
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After data cleaning and primary analyses, the de-identified data will be available to the scientific community upon formal request made to the AMPATH Research Manager. The data collection instruments will also be available upon request to the AMPATH Research Manager.
Publications
Naanyu V, Njuguna B, Koros H, Andesia J, Kamano J, Mercer T, Bloomfield G, Pastakia S, Vedanthan R, Akwanalo C. Community engagement to inform development of strategies to improve referral for hypertension: perspectives of patients, providers and local community members in western Kenya. BMC Health Serv Res. 2023 Aug 11;23(1):854. doi: 10.1186/s12913-023-09847-0.
PubMed 37568172Thakkar A, Valente T, Andesia J, Njuguna B, Miheso J, Mercer T, Mugo R, Mwangi A, Mwangi E, Pastakia SD, Pathak S, Pillsbury MKM, Kamano J, Naanyu V, Williams M, Vedanthan R, Akwanalo C, Bloomfield GS. Network characteristics of a referral system for patients with hypertension in Western Kenya: results from the Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) study. BMC Health Serv Res. 2022 Mar 7;22(1):315. doi: 10.1186/s12913-022-07699-8.
PubMed 35255913Mercer T, Njuguna B, Bloomfield GS, Dick J, Finkelstein E, Kamano J, Mwangi A, Naanyu V, Pastakia SD, Valente TW, Vedanthan R, Akwanalo C. Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial. Trials. 2019 Sep 9;20(1):554. doi: 10.1186/s13063-019-3661-4.
PubMed 31500661
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS)
- ClinicalTrials.gov ID
- NCT03543787
- Acronym / sponsor ID
- STRENGTHS / 1U01HL138636-01
- Conditions
- Hypertension
- Keywords
- Referral networks, low and middle income countries, PRECEDE-PROCEED, implementation research, hypertension, cardiovascular disease, process evaluation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Moi UniversityUniversity, hospital or other
- Collaborators
- Indiana University, Duke University, Icahn School of Medicine at Mount Sinai, Purdue University, University of Texas at Austin
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 1 Jun 2018 (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.
"STRENGTHS" is a transdisciplinary implementation research study, guided by the PRECEDE-PROCEED framework, to address the challenge of improving hypertension control in low-resource settings. The investigators propose to test the hypothesis that referral networks strengthened by an integrated health information technology and peer support intervention will be effective and cost-effective in improving hypertension control among patients in western Kenya. The investigators hypothesise that the integrated Health information Technology and Peer Support intervention will facilitate seamless referral of hypertensive patients across the different levels of the health system compared to usual care, leading to improvement in blood pressure. If proven to be successful, STRENGTHS can serve as a model for improving referral of patients upstream and downstream in health systems worldwide.
Detailed description
Hypertension is a major risk factor for cardiovascular disease, and 80% of global mortality due to cardiovascular diseases occurs in low- and middle-income countries. In low income countries, lack of coordination between different levels of the health system threatens the ability to provide the care necessary to control hypertension and prevent cardiovascular disease related morbidity. Strong referral networks have improved health outcomes for chronic disease in a variety of settings. Health information technology and peer-based support are two strategies that have improved care coordination and clinical outcomes. However, their effectiveness in strengthening referral networks to improve blood pressure control and reduce cardiovascular disease risk in low-resource settings is unknown.
The Academic Model Providing Access to Healthcare (AMPATH) partners with the Kenya Ministry of Health to provide care for non-communicable chronic diseases (NCDs), including hypertension at all levels of the health system. The Kenya Ministry of Health Sector Referral Strategy 2014-2018 calls for improving the referral system at every level of the health system. AMPATH has piloted both health information technology and peer support for NCDs, and both strategies are feasible in this setting. However, the impact of integrating Health information technology and peer support to strengthen referral networks for hypertension control is unknown.
The proposal's objective is to utilise the PRECEDE-PROCEED framework to conduct trans-disciplinary, translational implementation research focused on strengthening referral networks for hypertension control. The central hypothesis is "Health Information Technology integrated with peer support will be effective and cost-effective in strengthening referral networks, improving blood pressure control, and reducing cardiovascular risk among hypertensive patients in western Kenya." The investigators hypothesise that Health information technology(HIT) and peer support(PS) will synergistically address barriers to hypertension control at the patient, provider and health system levels. The investigators further hypothesise that changes in referral network characteristics may mediate the impact of the intervention on the primary outcome, and that baseline referral net-work characteristics may moderate the impact of the intervention. To test these hypotheses and achieve the overall objective, STRENGTHS has the following specific aims:
Aim 1: Conduct a baseline needs and contextual assessment for implementing and integrating HIT and PS to strengthen referral networks for hypertension control, using a mixed-methods approach, including: observational process mapping and gap assessment; baseline referral network analysis; and qualitative methods to identify facilitators, barriers, contextual factors, and readiness for change.
Sub-Aim 1.1: Use data from the aim 1 to develop a contextually and culturally appropriate intervention to strengthen referral networks for hypertension control using a participatory, iterative design process. Conduct pilot acceptability and feasibility testing of the intervention.
Aim 2: Evaluate the effectiveness of HIT and PS for hypertension control by conducting a two-arm cluster randomized trial comparing: 1) usual care vs. 2) referral networks strengthened with an integrated HIT-PS intervention. The primary outcome will be one-year change in systolic blood pressure and a key secondary outcome will be cardiovascular risk reduction.
Sub-Aim 2.1: Conduct mediation analysis to evaluate the influence of changes in referral network characteristics on intervention outcomes, and a moderation analysis to evaluate the influence of baseline referral net-work characteristics on the effectiveness of the intervention.
Sub-Aim 2.2: Conduct a process evaluation using the Saunders framework, evaluating key implementation measures related to fidelity, dose delivered, dose received, recruitment, reach, and context.
Aim 3: Evaluate the incremental cost-effectiveness of the intervention, in terms of costs per unit decrease in SBP, per percent change in CVD risk score, and per disability-adjusted life year (DALY) saved.
This research project will add to the existing knowledge base on innovative and scalable strategies for strengthening referral networks to improve control of NCDs in lower-MICs. If proven to be effective, it has the potential to be a scalable model for other low-resource settings globally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PRECEDE-PROCEED implementation research framework; 2-arm cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Health IT and Peer Support Intervention | Active comparator | Combination Product: Health IT and Peer Support InterventionUtilise electronic decision support, tracking of referral list and Peer facilitation for referral completion |
| Non intervention group | No intervention | –2014 - 2018 MoH referral protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >= 18 yrs
- Enrolled in AMPATH CDM Program
- meet criteria for referral up or down the network
Key exclusion criteria (3 listed)
- acute illness requiring immediate medical attention
- terminal illness
- inability to provide informed consent
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 |
|---|---|---|
| Health IT and Peer Support InterventionHealth IT will support referral system by establishing 1) communication between healthcare providers and peer navigators 2) decision support for clinician to facilitate appropriate referrals 3) tracking of referred patients real-time 4) dashboards to monitor key evaluation metrics. Peer Support intervention: peer navigators at each level of the referral network will ensure 1) referral adherence by link clinicians and patients 2) health system navigation 3) psychosocial support: leverage their shared disease experience to help patients overcome barriers to health seeking behaviour. | Combination product | Health IT and Peer Support Intervention |
Primary outcome
Change in one year systolic blood pressure as measured in clinic
Time frame: 1 year
The systolic blood pressure at baseline will be compared to systolic blood after 1 year of follow up. Blood pressure measurements will be averaged from three successive readings taken every 5 minutes in clinic
6 secondary outcomes
Change in one year overall Cardiovascular disease (CVD) QRISK2 score
Time frame: 1 year
Mortality
Time frame: 1 year follow up
Hospitalisation
Time frame: 1 year of follow up
Cardiovascular disease complications
Time frame: 1 year follow up
Change in number of CVD risk factors and behaviors as assessed using a standardised screening questionnaire
Time frame: 1 year
Self reported adherence to hypertension medication as assessed using the Morisky Medication adherence questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Derived from this study: PubMed 37568172Naanyu V, Njuguna B, Koros H, Andesia J, Kamano J, Mercer T, Bloomfield G, Pastakia S, Vedanthan R, Akwanalo C. Community engagement to inform development of strategies to improve referral for hypertension: perspectives of patients, providers and local community members in western Kenya. BMC Health Serv Res. 2023 Aug 11;23(1):854. doi: 10.1186/s12913-023-09847-0.
- Derived from this study: PubMed 35255913Thakkar A, Valente T, Andesia J, Njuguna B, Miheso J, Mercer T, Mugo R, Mwangi A, Mwangi E, Pastakia SD, Pathak S, Pillsbury MKM, Kamano J, Naanyu V, Williams M, Vedanthan R, Akwanalo C, Bloomfield GS. Network characteristics of a referral system for patients with hypertension in Western Kenya: results from the Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) study. BMC Health Serv Res. 2022 Mar 7;22(1):315. doi: 10.1186/s12913-022-07699-8.
- Derived from this study: PubMed 31500661Mercer T, Njuguna B, Bloomfield GS, Dick J, Finkelstein E, Kamano J, Mwangi A, Naanyu V, Pastakia SD, Valente TW, Vedanthan R, Akwanalo C. Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial. Trials. 2019 Sep 9;20(1):554. doi: 10.1186/s13063-019-3661-4.
- Individual participant dataSharing planned: Undecided. After data cleaning and primary analyses, the de-identified data will be available to the scientific community upon formal request made to the AMPATH Research Manager. The data collection instruments will also be available upon request to the AMPATH Research Manager.
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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.
Constantine O Akwanalo principal investigator
Moi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Health IT and Peer Support Intervention in people with Hypertension, run by Moi University at 1 site in Kenya.
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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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 Kenya. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 one year systolic blood pressure as measured in clinic (time frame: 1 year). 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 NCT03543787, which also lists 3 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 16 Mar 2023.