Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02771873 |
| Other study ID # |
LN0181 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2015 |
| Est. completion date |
January 14, 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Public Health Foundation of India |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The overall goal of the study is to test the effectiveness and sustainability of an
integrated care model for managing cardiovascular risk in individuals with family history of
premature coronary heart disease (CHD).
This care model involves:
1. screening for cardiovascular risk factors,
2. providing lifestyle interventions for prevention and management of cardiovascular risk
factors,
3. providing a framework for linkage to appropriate primary health care facility and
4. active follow-up of intervention adherence.
Initially, a formative qualitative research component will gather information on
understanding of diseases, barriers to care, specific components of the intervention package
(for example, context specific ways to enhance physical activity and to reduce prolonged
sitting time, ways to improve diet etc.) and feedback on the intervention strategies
(lifestyle education, care and linkage coordination). Then a randomized controlled trial
involving ~700 families and 1400 participants will be used to determine whether an integrated
care model is effective in reducing or halting the progression of CHD risk factors and risk
factor clustering in families. The sustainability and scalability of this intervention will
be assessed through economic and qualitative lenses to estimate value and acceptability.
Scalability will be informed by cost-effectiveness and acceptability of the integrated
cardiovascular risk reduction approach.
Description:
STUDY AIMS:
AIM 1. To identify barriers to implementing an integrated cardiovascular risk management
program in families of individuals with a positive history CHD.
AIM 2. To assess the effectiveness of an integrated cardiovascular risk management strategy
(consisting of screening for risk factors, lifestyle education and linkage to primary care
for cardiovascular risk factor management) on risk factor clustering in families, and changes
in blood pressure (BP), lipids, glucose, smoking and physical activity.
AIM 3. To estimate the scalability of the integrated cardiovascular risk reduction strategy
in families of individuals with a positive history CHD for state- or nation-wide
implementation. Scalability will be informed by cost-effectiveness and acceptability of the
integrated cardiovascular risk reduction approach.
STUDY DESIGN:
The proposed project uses mixed methods to achieve the study aims, the three design
approaches include:
Aim 1, formative qualitative research; Aim 2, a randomized controlled trial; and Aim 3, cost
effectiveness and evaluative qualitative research.
Additionally a pilot study will be conducted with the aim to understand the practical
feasibility of the study, acceptability among participants, appropriateness of the study
tools and finally to explore the interests of other stakeholders (community health workers
and department of health service, Government of Kerala). The pilot study will include only 30
participants. It is essentially to check the validity of the responses elicited from the
tools. We also plan to conduct two focus group discussions with the potential participants
(individuals with family history of CHD). Additionally, 6 in-depth interviews will be
conducted with community health workers (convenient sampling) to assess their opinion about
the intervention programme.
Formative qualitative research (Aim 1):
Semi-structured focus group discussions (FGDs) of 6-12 adults with family history of CHD will
gather information on understanding of diseases, barriers to care, and feedback on the
intervention (lifestyle education, care and linkage coordination). In-depth interviews with
stake-holders (frontline community health care workers (FCHW), primary care physicians, and
general practitioners) will be face-to-face and semi-structured and will include questions
regarding integration of cardiovascular risk management at the family level. The intervention
and trial protocols will be modified to incorporate key findings collected from FGDs and
interviews to make the intervention more contextually-relevant.
Integrated cardiovascular risk reduction intervention (Aim 2):
A randomized controlled trial of families of individuals with a positive history CHD will be
used to address Aim 2. Eligibility criteria: Eligible families include those with at least
one family member with physician confirmed CHD diagnosed before the age of 55 years. If there
are family members who have died from CHD (physician confirmed deaths) before the age of 55
years, such families will be also eligible to participate in the study. The medical records
of CHD patients will be used to confirm the diagnosis and the age of the index case. A
written informed consent to the study randomization plan from the head of the family is a
mandatory eligibility criteria. All participating family members will also be required to
provide individual consent to participate. Family randomization: Each family will randomly be
assigned to participate in either the treatment intervention arm (integrated CVD risk
management) or usual care arm (no interventions other than initial screening). Participants
eligibility criteria: Minimum of two members from each family will be included even if they
reside in separate houses. Potential participants must be either parents, children or
brothers and sisters of the affected person (individual with history of CHD) in order to
enter the study and more than 18 years of age.
Bedridden and terminally ill patients will be excluded from the study.
To address Aim 2, several clinical outcomes will be assessed. Primary outcome: proportions in
each group achieving or improving risk factor control status (blood pressure<140/90 mmHg,
fasting blood glucose (FPG)<110 mg/dl, low-density lipoprotein (LDL)<100 mg/dl, abstinence
from smoking/tobacco use: at least 3 out of 4 risk factors).
Secondary outcomes:
1. between group difference in number of optimal CV health indicators (BP<120/80 mmHg,
TC<200 mg/dl, FPG<100 mg/dl, >150 min/week of moderate intensity physical activity,
BMI<25 kg/m2, never used tobacco or quit >6 months ago and a healthy diet score),
2. between group mean difference in main risk factors (SBP, DBP, LDL, FPG),
3. proportions meeting >80% of recommended process measures (smoking cessation, moderate or
high intensity physical activity, and <5g per person/day salt consumption, >3 daily
servings of fruits and vegetables), and 4) proportions achieving or maintaining ten year
Framingham CVD risk score15/WHO CVD risk score of <10% or the INTERHEART non-laboratory
based score of <5.
Study Intervention Overview:
Usual care arm: The usual care arm will be screened for CVD risk factors. Screening results
plus one time education regarding management of risk factors will be provided to all family
members. Patients with hypertension, diabetes and dyslipidemia in the control arm will also
be referred to primary health care facility. Treatment arm: The study intervention is
designed to leverage the existing health care infrastructure available at the community
levels. Trained FCHW will be visiting the families to promote lifestyle intervention
strategies at least once in two months during the intervention phase.
The intervention consists of three phases: 1) screening and detection of CV risk factors, 2)
lifestyle (nutritional/physical activity education and tobacco cessation) counselling 2) FCHW
assisted linkage to primary care and 3) active follow-up through a mobile phone application.
Intervention Part 1. Screening for CV risk factors (CONTROL AND TREATMENT ARMS):
All eligible adults in the selected families will undergo a screening procedure for CVD risk
factors. The families will be randomized to either the treatment or control arm. At the start
of intervention program, high risk patients in the usual care arm will be referred to the
existing primary care system for further management.
Intervention Part 2. Lifestyle Education (TREATMENT ARM):
Lifestyle education intervention: The lifestyle education component of the treatment arm
includes a minimum of 9 nutritional/tobacco/physical activity consultations. All study
participants within the selected families in the treatment arm will participate in the
lifestyle education component. Within 30 days of study enrollment, all participants will
complete culturally specific food frequency questionnaires (FFQ) and tobacco use surveys.
FCHW will receive training from study staff prior to study implementation. Recommended diet
modifications for participants will focus on maintaining a healthy weight via
redistribution/reduction of calories (by avoiding fried foods and sugar-sweetened beverages),
increasing fiber and protein intake via wheat, and sprouted pulses, reducing glycaemic load
by switching from refined white rice and bread to whole wheat, increasing fruits and
vegetables consumption, and reducing salt and sugar intake. Tobacco cessation and strategies
to change the sedentary behaviour will also be discussed in education meetings. Current
tobacco users will complete culturally appropriate cessation action guides that identify
triggers and action steps to promote tobacco-free behaviours. Family consultations will be
repeated after once in every two months to re-assess dietary and tobacco use changes. FCHW
workers will conduct peer-support group education meetings with groups of 10 participants
once in every two months. Support group meetings will review diet modification and tobacco
cessation recommendations and highlight peers' strategies that have led to successful
improvement in diet. All individuals with elevated risk factors of CVD will be invited to
participate in at least 3 such peer-support group education during the period of the trial.
Intervention Part 3. Linkage to primary care (TREATMENT ARM):
All high risk patients from treatment arm will be linked to appropriate primary care clinics
with assistance from FCHW. FCHW workers will assist high risk patients to identify primary or
secondary care facilities and will help schedule initial appointments. For 24 consecutive
months following initial screening and randomization, participants from intervention arm will
receive quarterly phone interviews to measure primary care clinic utilization and to assess
cardiovascular risk factor management activities (lipids examined, smoking cessation
programs, hypertension control, glucose monitoring).
Care coordination and follow-up:
Each families, in the treatment arm will be assigned a FCHW. During the intervention phase
FCHW workers will meet with study patients once in two months to assess study progress and
participation in the initial six months. During intermediate-term follow-up (months 7-24)
FCHW will maintain once in three months contact with all families. In addition, questionnaire
data collection and blood draws at home visits after study months 12 and 24 will help to
assess detailed attributes of cardiovascular management (FBG, BP, and LDL measures). An
incentivized (free SMS credits) didactic mobile phone SMS platform will be used to enhance
follow-up. Via SMS, patients will receive study visit reminders and brief surveys.
Cost effectiveness and acceptability analyses (Aim 3):
The intervention costs will include the resource inputs (e.g., personnel salaries, and
materials) that are required to deliver the intervention (in total and per participant).
Direct and indirect costs incurred by each family will be estimated using questionnaires.
Questionnaires (administered at study visits 0, 12 and 24) will capture direct medical costs,
direct non-medical costs (travel), and indirect costs (missed work time, and lost
productivity). To estimate the cost-effectiveness (cost per one count decrease in clustering
of risk factors), the between trial group difference in intervention delivery and patient
direct costs will be divided by the between group difference in clustering of risk factors or
cardiovascular risk score: [costs treatment arm - costs standard arm]/[ΣΔPrimary
outcome-Treatment arm] - [ΣΔPrimary outcome-usual care arm]. Similarly, incremental cost
utility ratio will be calculated using data from a 12 monthly health utility assessment.
Quality adjusted life years (QALY) will be used as the measure of health utility.
The acceptability of the interventions will be assessed through qualitative research.
Semi-structured FGDs (6 each in men and women) will be conducted among study participants at
the end of the intervention period. In-depth interviews with FCHW (6 interviews) will be also
conducted to gauge the acceptability of the interventions.
