Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) (STRENGTHS)
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|ClinicalTrials.gov Identifier: NCT03543787|
Recruitment Status : Active, not recruiting
First Posted : June 1, 2018
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Combination Product: Health IT and Peer Support Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||PRECEDE-PROCEED implementation research framework; 2-arm cluster randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS)|
|Actual Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||January 28, 2023|
Active Comparator: Health IT and Peer Support Intervention
Utilise electronic decision support, tracking of referral list and Peer facilitation for referral completion
Combination Product: Health IT and Peer Support Intervention
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.
No Intervention: Non intervention group
2014 - 2018 MoH referral protocol
- 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
- Change in one year overall Cardiovascular disease (CVD) QRISK2 score [ Time Frame: 1 year ]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.
- Mortality [ Time Frame: 1 year follow up ]Death at the end of the study
- Hospitalisation [ Time Frame: 1 year of follow up ]Number of self-reported hospital admissions for hypertensive crises or heart failure among participants over one year follow up.
- Cardiovascular disease complications [ Time Frame: 1 year follow up ]Any cardiovascular complications including Heart failure, Stroke and Acute myocardial infarction
- Change in number of CVD risk factors and behaviors as assessed using a standardised screening questionnaire [ Time Frame: 1 year ]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
- Self reported adherence to hypertension medication as assessed using the Morisky Medication adherence questionnaire [ Time Frame: 1 year ]To assess changes in adherence to hypertension medications at one year from baseline as determined using the Morisky medication adherence questionnaire
- Referral network characteristics [ Time Frame: 1 year ]To assess the referral densities within the healthcare system.
- Referral proces characteristics [ Time Frame: 1 year ]To assess referral completion rates within the healthcare system
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543787
|Principal Investigator:||Constantine O Akwanalo||Moi Teaching and Referral Hospital|