Uptake of Task-Strengthening for Blood Pressure Control

NCT03490695 | Unknown DMC

• 1 other identifier: 7U01HL138638-04
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

Uptake of a community-based evidence-supported interventions for hypertension control in Ghana are urgently needed to address the cardiovascular disease epidemic and resulting illness, deaths, and societal costs. This study will evaluate the effect of Practice Facilitation on the uptake and maintenance of the evidence-based task-shifting strategies for hypertension control (TASSH) protocol across 70 Community-based Health Planning and Services (CHPS) zones delivered by trained community health officers. Findings from this study will provide policy makers and other stakeholders the "how to do it" empirical literature on the uptake of evidence-based interventions in Ghana, which may be applicable to other low-income countries.

Conditions

Hypertension; High Blood Pressure; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Rate of adoption of TASSH at the CHPS zones at 12-months

  This is a composite measure of adoption ratings to assess the degree to which the three essential elements of the TASSH protocol (identification and screening of patients for hypertension; proportion of patients who received lifestyle counseling by the Community Health Officers (CHOs); and proportion of hypertension (HTN) patients referred for initiation of drug treatment at the CHPS zones) are adopted

  12 months

Secondary Outcomes (3)

• Systolic BP reduction at 12 months (pre- and post-intervention)

  12 months

• Mediators of TASSH uptake at CHPS zones at 12 months

  12 months

• TASSH sustainability across the participating CHPS zones one year after PF intervention ends as measured by the maintenance of TASSH adoption ratings

  12 months

Study Arms (2)

Practice Facilitation Group A

EXPERIMENTAL

After the first 12 months of usual care (No Practice Facilitation), group A will begin to receive the Practice Facilitation (PF) Strategy at the CHPS compounds in addition to Ghana's National Health insurance and the World Health Organization (WHO) CVD Risk Assessment package.

Other: Practice Facilitation; Other: Usual Care

Practice Facilitation Group B

EXPERIMENTAL

Group B will receive Usual Care (no PF) between 12-24 months which includes Ghana's National Health Insurance, behavioral counseling and referral to care through the usual care system. After 24 months into the trial, Group B will then receive Practice Facilitation strategy in addition to Ghana's National Health insurance and the World Health Organization (WHO) CVD Risk Assessment package for a duration of another 12 months, as this is a stepped wedge design. During this 12 months period, practice facilitation will end in the Group A arm.

Other: Practice Facilitation; Other: Usual Care

Interventions

Practice Facilitation OTHER

Community health nurses trained in implementing the evidence-based TASSH protocol will be employed as Practice Outreach Facilitators (POF) to train the CHPS community health officers to deliver TASSH. The POFs will be required to complete an intensive 12-week training course focused on adoption of TASSH protocol to identify patients at risk for uncontrolled HTN, initiate behavioral lifestyle counseling, and Refer patients to the community health centers for drug therapy. Over the course of 12 months, the POFs will provide support to their assigned CHPS zones to implement TASSH as part of routine patient care.The POFs will also work with CHPS directors to review current work flow and develop a plan of action for TASSH uptake at the CHPS zones.

Practice Facilitation Group A; Practice Facilitation Group B

Usual Care OTHER

Provide Ghana's National Health Insurance, behavioral counseling and referral for care through the usual care system for 12 months.

Practice Facilitation Group A; Practice Facilitation Group B

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients registered to receive care at CHPS zone
• Adults age 40 years and older
• Have BP 140-179/90-100 mm Hg
• Able to provide informed consent

You may not qualify if:

• Previous diagnosis of diabetes, stroke, heart failure or chronic kidney disease BP\>180/100 mm Hg
• Positive urine dipstick for protein
• Pregnant
• Unable to provide informed consent
• Patients with history of stroke, heart failure, diabetes, angina, claudication, and BP\>180/100 mm Hg will be referred to a specialist

Sponsors & Collaborators

• Kintampo Health Research Centre, Ghana: lead
• NYU Langone Health: collaborator
• Kwame Nkrumah University of Science and Technology: collaborator
• St. Louis University: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Kintampo Health Research Centre

Kintampo, Ghana

Location

Related Publications (1)

• Asante KP, Iwelunmor J, Apusiga K, Gyamfi J, Nyame S, Adjei KGA, Aifah A, Adjei K, Onakomaiya D, Chaplin WF, Ogedegbe G, Plange-Rhule J. Uptake of Task-Strengthening Strategy for Hypertension (TASSH) control within Community-Based Health Planning Services in Ghana: study protocol for a cluster randomized controlled trial. Trials. 2020 Oct 2;21(1):825. doi: 10.1186/s13063-020-04667-7.

  PMID: 33008455 DERIVED

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Gbenga Ogedegbe, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Kwaku Poku Asante, PhD

  Kintampo Health Research Centre, Ghana

  PRINCIPAL INVESTIGATOR

• Juliet Iwelunmor, PhD

  St. Louis University

  PRINCIPAL INVESTIGATOR

• Jacob Plange-Rhule, MD

  Kwame Nkrumah University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Kweku Bedu-Addo, PhD

  Kwame Nkrumah University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: For the first 12-month of the study, the intervention will not be implemented as this is a stepped-wedged design. During this time period, primary outcome (adoption ratings) and secondary outcome (Systolic BP) data will be collected at the CHPS Zones following TASSH training and the PFOs will provide support to their assigned CHPS zones to prepare to implement the TASSH protocol. Each CHPS zones will then be randomly assigned to one of the two intervention arms: Group A will receive the Practice Facilitation Strategy at 12 months and Group B will initially serve as a Usual Care comparison group. Group B will then receive Practice Facilitation beginning 24 months into the trial, as this is a stepped wedge design. Sustainability for groups A and B will be assessed one year after the end of the intervention.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: April 6, 2018
• Study Start: November 14, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 1, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)