Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06081010 |
| Other study ID # |
2000036053 |
| Secondary ID |
1R01HL169421-01 |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2024 |
| Est. completion date |
December 2027 |
Study information
| Verified date |
April 2024 |
| Source |
Yale University |
| Contact |
Donna Spiegelman, ScD |
| Phone |
6178355119 |
| Email |
donna.spiegelman[@]yale.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this hybrid type III study incorporating a cluster-randomized trial is to assess
the effect of a community health worker-led hypertension prevention and control program
(CHPC) on the implementation outcomes and clinical outcomes among patient with hypertension
in central Nepal. The main questions it aims to answer are:
1. What is the level of implementation outcomes, including reach, adoption, implementation
fidelity, and maintenance of the CHPC implementation strategy at the patient, provider, and
health system levels? 2: What is the effectiveness of the CHPC implementation strategy
compared to facility-based intervention on systolic BP via a cluster randomized controlled
trial.
3: What is the implementation cost and cost-effectiveness of the CHPC implementation
strategy?
Participants will receive counseling and blood pressure monitoring services at their home
every four months for a year by a community health worker. Researchers will compare if there
is a significant difference in systolic blood pressure between those who receive this
intervention and those who do not receive the intervention in the same community.
Description:
INTRODUCTION HTN is a global public health challenge due to its high prevalence and
concomitant increased risk of cardiovascular disease (CVD).About 13.5% of global total
mortality is attributed to high blood pressure (BP) worldwide.3 In addition, about 54% of
strokes and 47% of coronary heart disease worldwide were attributable to high BP. In Nepal,
the adult HTN prevalence is 25%, similar to the global prevalence. Community Health Workers
(CHWs) are the frontline pillars of community-based health programs in Nepal, that can be
leveraged in support of HTN control efforts. CHWs play a pivotal role in Nepali culture - as
role models and health leaders in their communities and are highly respected in society.
Through CHW, investigators aim to influence HTN control and behavior change among adults and
society at large. By providing a replicable model for increasing HTN awareness, treatment,
and control in Nepal, investigators will accelerate the integration of effective intervention
into practice, providing an example of amelioration of the well-documented delays in moving
tested interventions to practice.To ensure relevance to policymakers, the investigators will
follow the principles of 'practical trials that include: (a) implementing the strategy, (b)
facilitating and evaluating the maintenance of the strategy beyond the implementation phase;
(c) using multiple evaluation measures relevant to decision makers, including reach,
adoption, and cost; and (d) evaluating effectiveness across multiple outcomes, with a plan to
triangulate findings from across multiple data sources using both qualitative and
quantitative measures.
METHODS investigators will conduct a Hybrid type III effectiveness-implementation design
focusing primarily on implementation outcomes while also collecting effectiveness outcomes as
they relate to the uptake or fidelity of the intervention. The primary implementation
outcomes (aim 1) - reach, adoption, implementation and maintenance - are selected to answer
the central research question of this study and will be assessed using a non-inferiority
design. Investigators will assess these outcomes in the intervention group using data from
the process evaluation in intervention health facilities. For each outcome, the null
hypothesis is that the percentages are equivalent to a set target or greater. Thus, if the
program is successful, investigators will be able to say with 95% confidence that these high
standards have been met. To measure the effectiveness (aim 2), Investigators will use a
cluster-randomized design to assess effectiveness in decreasing mean systolic BP in the
intervention group compared to the control group at 12 months after the intervention.
Investigators will also measure cost and estimate incremental cost per participant with
awareness on and control of high BP (aim 3).
STUDY SETTING Investigators will include basic health facilities in the Sindhupalchowk
district of Bagmati province. The reason is the need, these are hilly districts where there
are geographic challenges to deliver services through health facilities only. So, the CHW
program can have the highest impact by reaching a wider community to improve HTN awareness,
treatment, and control. In Nepal's hierarchical government structure, the provincial
government's commitment ensures high participation from health facilities. In the study
districts, there are 94 basic health facilities, and approximately 846 CHWs. These CHWs are
female community health volunteers (FCHV) who provide basic health services in Nepal,
particularly to women.
Intervention (Implementation Strategies)
Investigators will include reporting on the progress of this program in the quarterly health
system review meetings to ensure continuous discussion of the program. For both training of
healthcare providers (3 days) and CHWs (3 days) the training will focus on three objectives:
(a) build knowledge of the package of essential non communicable disease (PEN) program
protocols-1 and 2; (2) build skills to implement and maintain the program including effective
communications, program promotion, engaging HTN patients; and reflecting on and evaluation
progress and quality of implementation; and (3) build skills for barriers management,
including strategies to address barriers to intervention delivery, such as defining and
setting aside times for HTN patients to participate in discussing and addressing barriers to
the successful implementation of HTN detection and control. After receiving the training,
CHWs will conduct group meetings and home visits in households in their catchment area and
measure BP. Each CHW will take the high BP clients (>=140/90) to the nearest health center.
They will enlist the individuals with HTN and conduct three follow-up visits or group
meetings with these participants, every four months. Using concepts from 'learning networks
investigators will create information exchanges for both health care workers and CHWs leading
to shared problem-solving, learning from each others' experiences, and support for program
implementation.
Data Sources, Measures, and Analysis by Specific Aim
1. Community Survey: Investigators will conduct baseline and endline client surveys with an
anticipated total of 3572 participants. Trained research assistants will collect the
following data using a face-to-face interview technique: Sociodemographic data such as
age (years), gender (male/female/other), marital status (married/unmarried/widow),
highest education attained, occupation (government/ self-employed/ private/ unemployed),
annual household and per capita income using validated questionnaire;(2) Lifestyle
factors such as fruits and vegetable intake using diet quality questionnaire, physical
using a global physical activity questionnaire, alcohol (drinks per week) and smoking
(cigarettes per day), knowledge of hypertension, and medication. (3) Blood pressure will
be taken during baseline and endline. an 'Omron' digital instrument three times in a
resting position with an internal of at least 5 minutes.
2. Health care workers survey: Healthcare workers in all health facilities will be asked to
complete a survey assessing CHPC implementation, any HTN control efforts, and their BP
and lifestyle status. (c) Process tracking: The process tracking system will also serve
as a monitoring tool to support program implementation and maintenance. CHW will be
asked by health care worker to complete a monthly checklist to capture completed
intervention activities, including records of patients attended. Study staff will make
monthly phone calls to healthcare workers to ensure collection of these data. (d) Focus
group discussions: Investigators will conduct 6-9 FGDs with CHWs purposively at
post-implementation and post-maintenance to identify key implementation facilitators and
barriers. (e) Key informant interviews (KII): With provincial ministry of health and
municipal officials in the selected municipality at two-time points (post-implementation
and post-maintenance) investigators will explore factors influencing support for the
program and their perceptions of barriers and facilitators to the program among 16 key
informants expecting to reach data saturation.
Data analysis for the primary aim: reach, adoption, implementation and maintenance
Investigators will compute estimates of adoption, implementation, reach, and maintenance,
with appropriate 95% confidence intervals. Investigators will conduct abductive analysis,
using first inductive codes (e.g., emerging from the data) and transposing these into
deductive consolidated framework for implementation research (CFIR) constructs. Investigators
will compile codes and clear definitions of codes into a codebook and apply them to the data
using NVivo 12.0, with regular team meetings to ensure consistency across coders.
Aim 2. Effectiveness To assess the effectiveness, investigators are planning for 2432
patients, 14 in the cluster to be enrolled over the period of 6 months. Power was set at 80%
and level of significance at 5% to observe a minimum detectable mean difference between arms
at 12 months of 3 mmHg systolic BP (primary outcome). There is evidence that 5 mmHg decrease
in systolic BP at the population level reduces the risk of CVD by 10 percent. Investigators
set the standard deviation of 17 mmHg for HTN based on a previous trial, assumed 10% loss to
follow up, and intra-cluster coefficient (ICC) 0.015 to account for clustered design. The
baseline characteristics of each arm will be presented as the mean (standard deviation) or,
median (interquartile) for continuous; and frequency (%) for categorical variables. Primary
analyses of the outcome, mean systolic BP at 12 months, will follow an intention-to-treat
approach, by estimating the change in systolic BP between the intervention and control group
using a generalized estimation equation (GEE ) with an identity, exchangeable working
correlation, and robust variance. If a substantial baseline imbalance between randomized
groups is identified, an additional adjusted sensitivity analysis will be performed including
predefined variables (age, marital status, education) to assess the robustness of the primary
analysis. Investigators will also use ANCOVA for clustered data to conduct
difference-in-difference analysis. In the secondary 'per protocol' analyses, the participants
will be excluded if they (i) received less than 2 home visits; or (ii) were found not
eligible based on the inclusion and exclusion criteria after randomization and will be
compared to all participants in the control group.
Aim 3: Economic and Financial Sustainability Investigators will calculate the total costs of
the implementation and maintenance years by summing the costs of the individual components.
Investigators will determine associations for total and component costs with co-factors,
rural/urban location, health facility catchment area, and CHW-to-beneficial ratio. The cost
will also be used for projecting the financial expenditures of implementation and
maintenance, and ultimately, scale up across the estates over time, to facilitate budgetary
planning and resource allocation at the level of municipality. Investigators will estimate
the cost-effectiveness in terms of incremental cost per HTN awareness, and incremental cost
per BP controlled client. The primary analysis will take a financial perspective and
secondary analysis will take a societal perspective. Sensitivity analysis will be done using
financial costs only - specifically by using the discounted medicine costs available to the
program - to show difference in cost-effectiveness with and without full social costs
accounted for.
