Impact of a Climate-Adapted Self-Management Intervention for Hypertension: A Randomized Controlled Trial Examining Psychosocial and Environmental Determinants
1 other identifier
interventional
44
1 country
3
Brief Summary
This study aims to evaluate the effectiveness of a Climate-Adapted Self-Management Intervention in improving the quality of life among adults with hypertension. The study employed a two-phase design comprising a cross-sectional survey followed by a randomized controlled trial. The intervention was evaluated for its effects on quality of life, psychological distress, health behaviors, environmental determinants, and blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable quality-of-life
Started Feb 2026
Shorter than P25 for not_applicable quality-of-life
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
July 18, 2026
CompletedFirst Posted
Study publicly available on registry
July 22, 2026
CompletedJuly 28, 2026
July 1, 2026
3 months
July 18, 2026
July 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
World Health Organization Quality of Life Scale Urdu Version
It is a 26-item instrument that measures four domains: physical health, psychological health, social relationships, and environmental health. A total score was calculated by summing the responses to all 26 items, with a possible score range of 26 to 130. Higher scores indicate better quality of life, whereas lower scores indicate poorer quality of life.
3 months
Study Arms (2)
Experimental
EXPERIMENTALWho receives the intervention, i.e., Climate-Adapted Self-Management Intervention
Waitlist Control
ACTIVE COMPARATORWho 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Severe chronic physical illness (e.g., neurological disorders, cancer, severe cardiac conditions, stroke, diabetes, or other chronic diseases besides hypertension).
- Chronic psychological illness.
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Capital Hospital Islamabad
Islamabad, Islamabad, 46000, Pakistan
Fauji Foundation Hospital
Rawalpindi, Punjab Province, 45000, Pakistan
Cantonment Board General Hospital Rawalpindi
Rawalpindi, Punjab Province, 46000, Pakistan
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Ayesha Sohail, Mphil Scholar
Fatima Jinnah women University, Rawalpindi, Pakistan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 18, 2026
First Posted
July 22, 2026
Study Start
February 1, 2026
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
July 28, 2026
Record last verified: 2026-07