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- Ensaio Clínico NCT07720752
Impact of a Climate-Adapted Self-Management Intervention for Hypertension: A Randomized Controlled Trial Examining Psychosocial and Environmental Determinants
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Islamabad
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Islamabad, Islamabad, Paquistão, 46000
- Capital Hospital Islamabad
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Punjab Province
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Rawalpindi, Punjab Province, Paquistão, 45000
- Fauji Foundation Hospital
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Rawalpindi, Punjab Province, Paquistão, 46000
- Cantonment Board General Hospital Rawalpindi
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Experimental
Who receives the intervention, i.e., 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.
|
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Comparador Ativo: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
World Health Organization Quality of Life Scale Urdu Version
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ayesha Sohail, Mphil Scholar, Fatima Jinnah women University, Rawalpindi, Pakistan
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FJWU/EC/2026/145
Informações sobre medicamentos e dispositivos, documentos de estudo
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