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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

Saju 2021.

Study name Swāsthya, an integrated chronic condition management programme for families of patients with hypertension and diabetes mellitus
Methods Study design: cluster‐RCT
Country: India
Participants Families of patients with hypertension and diabetes mellitus
Inclusion criteria: 
a. Eligible families will be those with at least one family member with a confirmed diagnosis of HTN and/or DM.
b. Family members must be either first‐degree blood relatives or spouses of the patient.
Exclusion criteria:
a. bedridden and terminally ill patients
Stated purpose: to improve treatment adherence and medical compliance by addressing social, behavioural, and cognitive barriers to ensure the control of chronic conditions such as HTN and DM
Interventions Intervention:
Swāsthya intervention (social, behavioural, and cognitive or multiple interventions)
The package comprising five separate modules on general, behavioural, social, cognitive, and multiple interventions prepared by the research team. General interventions will be delivered to all participants included in the intervention arm. Behavioural, social, and cognitive interventions will be separately administered to participants based on the group they belong to (behavioural risk, social risk and cognitive risk groups). For the fourth group, that is, the multiple risk groups, interventions will be customised based on their priority needs. All the interventions are developed targeting the entire family.
Control:
Usual care (patients with HTN and/or DM in the control arm will be referred to PHCs or encouraged to access their preferred health care facility)
Outcomes Participants'outcomes of interest for this review

  1. Mental health symptoms/depression – Depression Anxiety Stress Scale (DASS‐21)

  2. Mental health symptoms/anxiety – Depression Anxiety Stress Scale (DASS‐21)

  3. Mental health symptoms/distress/PTSD – Depression Anxiety Stress Scale (DASS‐21)

  4. Social outcomes (social cohesion) – Social Cohesion questionnaire


Economic outcomes
Nil
Time points: baseline, post‐intervention (6 months and 12 months post‐baseline)
Starting date 1 February 2021 (recruitment start date)
Contact information M D Saju, saju@rajagiri.edu or sajumadavan@gmail.com
Notes Source of funding: Rajagiri College of Social Sciences (Autonomous) and IMPRESS, ICSSR under the grant number IMPRESS/P798/2045/2018‐19/ICSSR
Prospective trial registration number: CTRI/2020/12/029474