Assessment of acceptability of the comprehensive Ayurveda-based health care approach in the tribal community and effectiveness of individualized health care - Cluster randomized study
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 7,280
- 试验地点
- 14
- 主要终点
- Any change in perception & health-
研究概览
简要总结
The present study is being conducted to assess the impact of comprehensive
Ayurveda-based health care approach (CABHA) and individualized Ayurveda health
care approach (IAHA) in the specified community. It is a Quasi-experimental study
design in which willing participants of any sex aged > 18 years and belonged to
scheduled Tribe will be enrolled. The duration of study will be 12 months with a
total sample size 7280 (520/ Centre for CABHA*14 center), 420 (30 families /28 Centre for
IAHA). There will be two clusters. In cluster 1 CABHA and IAHA will be given and in
cluster 2 only CABHA will be given for four months. Primary outcome will be
proportion of change in perception & health-seeking behavior of the selected
population after introduction of the CABHA and it will be assessed through a
questionnaire administered among the randomly selected sample for survey in two
clusters, before and after the interventions in the community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •For CABHA Eligibility Assessment for participation in the survey
- •Of age ≥18 years
- •Able to respond or communicate
- •Willing to participate in the survey For IAHA (Applicable only on Cluster -1) 1.The families residing in the identified areas and consisting of at least 2 members and, at least one among them is aged ≥18 years 2.At least one adult member in the family is willing to participate in this study for the 4 months.
排除标准
- •The families those are planning to move out of the identified area during the study period.
- •Families whose members cannot dedicate any suitable time for the activities involved in this study (personal interview and counseling).
结局指标
主要结局
Any change in perception & health-
时间窗: at baseline & after 4 Months
seeking behavior of the selected
时间窗: at baseline & after 4 Months
population after introduction of the
时间窗: at baseline & after 4 Months
CABHA
时间窗: at baseline & after 4 Months
(To be assessed through a questionnaire administered
时间窗: at baseline & after 4 Months
among the randomly selected sample for survey in two
时间窗: at baseline & after 4 Months
clusters of the community)
时间窗: at baseline & after 4 Months
次要结局
- 1.Any change in the score of quality of life (SF-12) of the(surveyed participants)
- Any change in the score of Immune Status Questionnaire((ISQ) in the participants from the included families)
- 3.Any change in WHO-5 Wellbeing Index score of the(participants from the included families)
- 4.Any change in the score of Global Sleep Assessment(Questionnaire (GSAQ) of the participants from the included)
- 5.Any change in the Oral Health Assessment Tool (OHAT)(score of the participants from the included families)
- 6.Any change in the scores of disease specific patient(reported outcomes of the participants in the community)
- 7.Proportion of participants adhering (≥60%) to the(Ayurveda advocacy and/or treatment throughout the)
- 8.Trend in rise of OPD attendance in the outreach OPDs(during the intervention period)
研究者
Dr Kalpana Kachare
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush