Programme of Lifestyle Intervention in Families for Cardiovascular Risk Reduction
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Integrated cardiovascular disease risk management.
Intervention type(s): Behavioral
Intervention description(s): Health promotion intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention