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

18 juillet 2026 mis à jour par: Ayesha Sohail, Fatima Jinnah Women University
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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

44

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • 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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Experimental
Who receives the intervention, i.e., Climate-Adapted Self-Management Intervention
Comportemental: 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.
Comparateur actif: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
World Health Organization Quality of Life Scale Urdu Version
Délai: 3 months
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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fatima Jinnah Women University

Les enquêteurs

  • Chercheur principal: Ayesha Sohail, Mphil Scholar, Fatima Jinnah women University, Rawalpindi, Pakistan

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2026

Achèvement primaire (Réel)

1 mai 2026

Achèvement de l'étude (Réel)

1 mai 2026

Dates d'inscription aux études

Première soumission

18 juillet 2026

Première soumission répondant aux critères de contrôle qualité

18 juillet 2026

Première publication (Réel)

22 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • FJWU/EC/2026/145

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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