Assessment of a psychological intervention by community health volunteers for hypertension in rural settings in Alappuzha in Kerala - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
A Psychological intervention delivered by trained Community Volunteers can decrease Blood Pressure in persons with Hypertension. The Objective of the study is to test whether and how a psychological intervention delivered by community volunteers works on people with Hypertension and obtain data on effect to design the main trial to test its effectiveness. This is a Cluster non randomised - pre and post intervention design mixed methods and study is conducted in Muhamma panchayat in Alappuzha district in Kerala. The sample size is of 160 participants, and they are selected based on the inclusion and exclusion criteria.
The screening for the psychological distress will be done using DASS 21 Questionnaire, Baseline measurements include BP measurements, Quality of Life (QOL) Scores measured by EQ-5D-5L, medication adherence measured using Hill Bone Medication Adherence Scale. The intervention will be delivered by Community Health Volunteers twice. First intervention will be face to face sessions for 8 weeks. Measurements on BP, Distress, QOL and adherence will be collected immediately after the intervention. There will be a follow up intervention over phone for 8 weeks and measurements on BP, Distress, QOL and adherence will be collected following this intervention. Qualitative assessment (focus group discussions and in- depth interviews (IDI)) will be conducted with key stakeholders which include patients and family members to study process indicators.
The outcome measures include Blood Pressure changes, Distress Scores, Quality of life Scores, Adherence Scores, process indicators - recruitment, retention, numbers, numbers engaged, followed up, dropped out, any adverse event, satisfaction, readiness, challenges, and barriers indicating acceptability, appropriateness, adoption and feasibility.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults over 30 years and above and below or equal to 75 years will be recruited who have been diagnosed with Hypertension and are on Antihypertensive medication and / or lifestyle measures.2) The diagnosis of Hypertension by the Physician is made when the mean of three BP measurements recorded 5 minutes apart with Diastolic BP greater than or equal to 90 mm Hg and/ or Systolic BP greater than 140 mm Hg.
排除标准
- •Those above 75 years, 2)Those with BP greater than or equal to 180/100 mm Hg, 3)Those who have had a Cerebrovascular Accident (CVA),Severe Heart Failure (heart failure NYHA Classification 111 and IV),bedridden, difficulty in engaging with the volunteers due to physical Co morbidities /Cognitive Impairment/ Mental Illness already on /or requiring Pharmacological management will be excluded.
研究者
Dr Chitra Venkateswaran
Department of Community Medicine, Amrita Viswa Vidyapeetham, Amrita Institute of Medical Sciences Kochi Campus