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临床试验/CTRI/2025/12/099926
CTRI/2025/12/099926尚未招募不适用

Effectiveness of Family-Based Counselling for Reducing Non-Communicable Disease Risk Behaviours and Outcomes among Hypertension patients: A Randomized Controlled Trial in Urban Chandigarh for a period of 6 months

PGIMER Chandigarh2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
2
主要终点
Change in physical activity, diet, mental health, tobacco, alchohol use andmedicine aherence among participants

研究概览

简要总结

This study is a two-arm randomized controlled trial conducted in peri-urban areas of Chandigarh to assess the effectiveness and feasibility of family-based counselling for hypertension management. Adults aged 30–69 years with diagnosed hypertension will be randomized to receive either structured family-based counselling or routine standard care, with a total sample of 120 participants followed for six months. The intervention focuses on key modifiable NCD risk factors including diet, physical activity, tobacco and alcohol use, stress management, and medication adherence, and involves adult family members through four counselling contacts. Baseline and endline assessments will measure changes in behavioural risk factors, medication adherence, and blood pressure control among participants, as well as risk behaviours among family members. Effectiveness will be evaluated through pre–post comparisons between intervention and control groups, while feasibility, acceptability, and relevance of implementing the intervention at the primary healthcare level will be assessed using validated questionnaires and qualitative methods.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 69.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with Primary Hypertension.

排除标准

  • Terminally ill patients.
  • Patients with Secondary Hypertension.

结局指标

主要结局

Change in physical activity, diet, mental health, tobacco, alchohol use andmedicine aherence among participants

时间窗: 0 and 6 months

次要结局

  • Change in disease control status among participants(Change in behaviour determinants among family members)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Smriti Jain

PGIMER, Chandigarh

研究点 (2)

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