Impact of a Climate-Adapted Self-Management Intervention for Hypertension: A Randomized Controlled Trial Examining Psychosocial and Environmental Determinants

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Psychological Distress; Health Behaviors; Climate Change Anxiety; Heatwave Knowledge, Awareness, Practices, and Behaviors
• Intervention / Treatment: Behavioral: Climate-Adapted Self-Management Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad
    • Islamabad, Islamabad, Pakistan, 46000
      • Capital Hospital Islamabad
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan, 45000
      • Fauji Foundation Hospital
    • Rawalpindi, Punjab Province, Pakistan, 46000
      • Cantonment Board General Hospital Rawalpindi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults aged 25-65 years.
2. Clinically diagnosed with primary hypertension by a medical professional.
3. Receiving antihypertensive medication for at least one year.
4. Able to read and understand English.
5. Access to internet services for participation in online intervention sessions.
6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Severe chronic physical illness (e.g., neurological disorders, cancer, severe cardiac conditions, stroke, diabetes, or other chronic diseases besides hypertension).
2. Chronic psychological illness.
3. Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Who receives the intervention, i.e., Climate-Adapted Self-Management Intervention	Behavioral: Climate-Adapted Self-Management Intervention; 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.
Active Comparator: 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.	Behavioral: Climate-Adapted Self-Management Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Higher scores indicate a better quality of life, and lower scores indicate a lower quality of life	3 months

Collaborators and Investigators

• Sponsor: Fatima Jinnah Women University
• Investigators: Principal Investigator: Ayesha Sohail, Mphil Scholar, Fatima Jinnah women University, Rawalpindi, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Actual): May 1, 2026
• Study Completion (Actual): May 1, 2026

Study Registration Dates

• First Submitted: July 18, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Behavior; Behavior
• Other Study ID Numbers: FJWU/EC/2026/145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No