- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07720752
Impact of a Climate-Adapted Self-Management Intervention for Hypertension: A Randomized Controlled Trial Examining Psychosocial and Environmental Determinants
연구 개요
상태
상세 설명
The study was conducted in two phases. Phase I consisted of a cross-sectional survey that examined psychosocial factors, health behaviors, environmental determinants, and quality of life among adults with hypertension. Participants were recruited from public and private hospitals in Rawalpindi and Islamabad using convenience purposive sampling.
Phase II consisted of a two-arm, parallel-group randomized controlled trial. Eligible participants identified during Phase I were randomly assigned to either the experimental group or the wait-list control group. The experimental group received the Climate-Adapted Self-Management Intervention in addition to usual medical care, whereas the wait-list control group received usual medical care together with generic health information during the study period. The intervention comprised six structured sessions delivered over 6 weeks, with one session per week lasting approximately 40-45 minutes. The sessions included self-management education, healthy lifestyle promotion, stress management, mindfulness, climate change awareness, heatwave preparedness, and behavioral coping strategies.
The Climate-Adapted Self-Management Intervention was adapted from the Chronic Disease Self-Management Program (CDSMP) of the Self-Management Resource Center (SMRC), USA, with permission. The principal investigator completed SMRC training before implementing the intervention.
Outcome assessments were conducted at baseline and immediately after completion of the intervention. The primary outcome was quality of life, while secondary outcomes included psychological distress, health behaviors, climate change anxiety, heatwave-related knowledge, awareness, practices and behaviors, and blood pressure. The effectiveness of the Climate-Adapted Self-Management Intervention was evaluated by comparing post-intervention outcomes between the experimental and wait-list control groups. After completion of the post-intervention assessment, the Climate-Adapted Self-Management Intervention was also offered to participants in the wait-list control group to ensure equitable access to the intervention.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Islamabad
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Islamabad, Islamabad, 파키스탄, 46000
- Capital Hospital Islamabad
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Punjab Province
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Rawalpindi, Punjab Province, 파키스탄, 45000
- Fauji Foundation Hospital
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Rawalpindi, Punjab Province, 파키스탄, 46000
- Cantonment Board General Hospital Rawalpindi
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 25-65 years.
- Clinically diagnosed with primary hypertension by a medical professional.
- Receiving antihypertensive medication for at least one year.
- Able to read and understand English.
- Access to internet services for participation in online intervention sessions.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Severe chronic physical illness (e.g., neurological disorders, cancer, severe cardiac conditions, stroke, diabetes, or other chronic diseases besides hypertension).
- Chronic psychological illness.
- Pregnancy.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Experimental
Who receives the intervention, i.e., Climate-Adapted Self-Management Intervention
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The Climate-Adapted Self-Management Intervention is a behavioral intervention developed for adults with hypertension.
It integrates evidence-based self-management strategies with climate-related health education.
The intervention is delivered in six sessions, one session per week, with each session lasting approximately 40-45 minutes.
Sessions include psychoeducation, self-management skills, healthy lifestyle promotion, medication adherence, stress management, mindfulness, climate change awareness, heatwave preparedness, behavioral coping strategies, goal setting, and relapse prevention.
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활성 비교기: Waitlist Control
Who receives usual medical care, along with generic health information, throughout the study period and receive the Climate-Adapted Self-Management Intervention once the study is completed.
|
The Climate-Adapted Self-Management Intervention is a behavioral intervention developed for adults with hypertension.
It integrates evidence-based self-management strategies with climate-related health education.
The intervention is delivered in six sessions, one session per week, with each session lasting approximately 40-45 minutes.
Sessions include psychoeducation, self-management skills, healthy lifestyle promotion, medication adherence, stress management, mindfulness, climate change awareness, heatwave preparedness, behavioral coping strategies, goal setting, and relapse prevention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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World Health Organization Quality of Life Scale Urdu Version
기간: 3 months
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It is a 26-item instrument that measures four domains: physical health, psychological health, social relationships, and environmental health.
Higher scores indicate a better quality of life, and lower scores indicate a lower quality of life
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ayesha Sohail, Mphil Scholar, Fatima Jinnah women University, Rawalpindi, Pakistan
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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