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

N/ACompletedNCT07720752

Fatima Jinnah Women University44 enrolled

Overview

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.

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

Interventions

Climate-Adapted Self-Management InterventionBEHAVIORAL

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

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 3 months