- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07572045
Promoting Interventions for Climate Change to Upscale Resilience in District Badin (PICCTURE)
Promoting Interventions for Climate Change to Upscale Resilience (PICCTURE) Trial in District Badin
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
District Badin, located in the lower Indus delta of Pakistan, is highly exposed to recurrent climate-related hazards, including riverine and coastal flooding, cyclones, saline water intrusion, and increasing temperatures. These hazards interact with underlying structural vulnerabilities such as low-lying topography, reliance on agriculture and fisheries, and constrained access to health and social services-resulting in compounded risks to health, nutrition, and livelihoods. This context provides a suitable setting to evaluate integrated, community-based strategies aimed at strengthening resilience to climate-related shocks.
This study is guided by a multidimensional resilience framework that conceptualizes resilience as a function of coping, adaptive, and transformative capacities across social, economic, environmental, and health domains. The intervention package is informed by prior vulnerability assessments and designed to address key modifiable determinants of resilience, including disaster preparedness, livelihood security, financial risk management, and access to essential health services.
The intervention is delivered through two implementation models that differ in the degree of health system integration. The first model utilizes community-led platforms established through Village Management Committees (VMCs), which are locally constituted groups representing diverse segments of the community. These committees facilitate participatory learning and action processes, enabling communities to identify risks, prioritize solutions, and implement locally appropriate adaptation strategies. Core components include structured training on disaster risk reduction, development of community hazard maps and early warning mechanisms, promotion of climate-resilient livelihood options, and strengthening of household-level financial planning and emergency preparedness.
The second model builds on the community platform by incorporating structured engagement with Lady Health Workers (LHWs) and primary healthcare providers. This integrated approach is intended to strengthen linkages between communities and the formal health system, enhance delivery of climate-sensitive health messaging, improve identification and support of high-risk households, and facilitate continuity of care during climate-related events. Health system engagement also includes co-facilitation of selected community sessions, alignment of community preparedness plans with facility-level response mechanisms, and promotion of climate-responsive service delivery practices.
Intervention activities are implemented over a 12-month period using a standardized curriculum adapted to the local context. Delivery follows a phased approach, with more intensive engagement during the initial months followed by reinforcement sessions. Participatory group sessions, simulation exercises, and community mobilization activities are used to enhance knowledge, build skills, and support behavior change. Implementation fidelity is supported through structured training of facilitators, supervision, routine monitoring, and the use of standardized tools and materials.
Evaluation is conducted using repeated cross-sectional household surveys administered at baseline and endline to assess changes in resilience and vulnerability across multiple domains. Data collection includes measures of household preparedness, livelihood strategies, financial coping mechanisms, health-seeking behavior, and selected health and nutrition indicators. Process evaluation is embedded within the study to assess intervention delivery, including coverage, participation, adherence to planned activities, and functionality of community-level preparedness mechanisms such as emergency plans and early warning systems. These measures enable assessment of both implementation fidelity and intermediate pathways of impact.
To capture the effectiveness of interventions under real-world stress conditions, a rapid assessment component is incorporated. In the event of a major climate-related hazard affecting study areas during the implementation period, targeted data collection will be conducted shortly after the event to document community responses, functioning of preparedness systems, and access to essential services. This component is intended to complement routine evaluation by providing insight into intervention performance during actual shocks.
The analytical approach follows an intention-to-treat framework, whereby all households are analyzed according to their assigned study group regardless of level of participation. Intervention effects will be estimated using mixed-effects regression models to account for clustering at the community level and potential intra-cluster correlation. A difference-in-differences specification will be applied to compare changes over time between study groups, enabling estimation of intervention effects while controlling for baseline differences and secular trends. Models will incorporate fixed effects for time and study group, as well as interaction terms to estimate differential changes attributable to the intervention. Relevant household- and cluster-level covariates will be included to improve precision and adjust for residual confounding.
Sensitivity analyses will be conducted to assess the robustness of findings to model specification and potential sources of bias, including differential attrition and variation in intervention exposure. Process indicators will be analyzed descriptively and, where appropriate, linked to outcome measures to explore potential mechanisms of effect.
This study is designed to generate rigorous evidence on the effectiveness of integrated community-based and health system-linked approaches to strengthening climate resilience in vulnerable populations. Findings are expected to inform the design and scale-up of adaptation strategies in similar climate-affected, resource-constrained settings.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Akber Ali, Masters
- Número de telefone: +92-307-777-1403
- E-mail: akber.ali@aku.edu
Estude backup de contato
- Nome: Dr. Jai Kumar Das, PhD
- Número de telefone: 0213486 69826
- E-mail: jai.das@aku.edu
Locais de estudo
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Sindh
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Karachi, Sindh, Paquistão
- Aga Khan University
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Contato:
- Akber Ali, Masters
- Número de telefone: +92-307-777-1403
- E-mail: akber.ali@aku.edu
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Contato:
- Dr. Jai Kumar Das, PhD
- Número de telefone: 0213486 69826
- E-mail: jai.das@aku.edu
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Investigador principal:
- Dr. Jai Das, PhD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Permanent residents of the selected study area
- Aged 18 years and above
- Willing to provide informed consent
Exclusion Criteria:
1-Temporary residents or non-residents of the study area
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Community Interventions (CI)
Os clusters recebem um pacote estruturado de intervenções de adaptação e resiliência lideradas pela comunidade através dos Comités de Gestão da Aldeia (VMCs).
As atividades incluem sessões de formação e participativas sobre redução do risco de desastres, diversificação de meios de subsistência, literacia financeira e conscientização para a saúde.
As sessões são conduzidas com abordagens de aprendizagem participativa para fortalecer a capacidade adaptativa dos agregados familiares e da comunidade.
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A structured package of community-led activities delivered through Village Management Committees, including participatory training on disaster risk reduction, livelihood diversification, financial literacy, and health awareness to strengthen household and community resilience.
|
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Experimental: Intervenção Comunitária + Cuidados de Saúde Primários (IC+CSP)
Os clusters recebem as mesmas intervenções comunitárias do Braço 1, com envolvimento adicional dos Lady Health Workers e dos prestadores de cuidados de saúde primários.
Os atores do sistema de saúde apoiam a prestação de componentes relacionados com a saúde, promovem a procura de cuidados e fortalecem as ligações entre as comunidades e os serviços de saúde para melhorar os resultados de resiliência.
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A structured package of community-led activities delivered through Village Management Committees, including participatory training on disaster risk reduction, livelihood diversification, financial literacy, and health awareness to strengthen household and community resilience.
Lady Health Workers and primary healthcare providers to reinforce interventions delivered through VMCs and strengthen linkages between communities and health services.
|
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Sem intervenção: Controle
Os clusters não recebem qualquer intervenção adicional para além dos serviços existentes e das condições padrão durante o período do estudo.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Household disaster resilience
Prazo: At baseline and endline (12 month)
|
Household disaster resilience will be assessed using the Disaster Resilience Index (DRI), a validated multidimensional composite measure of a household's ability to withstand, adapt to, and recover from shocks.
The DRI comprises three domains: Coping Capacity, reflecting baseline resources and conditions that enable immediate response; Adaptive Capacity, capturing the ability to adjust and respond effectively through access to systems, resources, and support; and Transformative Capacity, measuring longer-term potential to learn, improve, and strengthen resilience over time.
The score ranges from 0 to 1, with higher values indicating greater household resilience.
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At baseline and endline (12 month)
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Household vulnerability
Prazo: At baseline and endline (12 month)
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Household vulnerability will be assessed using the Multidimensional Livelihood Vulnerability Index (MLVI), a validated composite measure capturing susceptibility to shocks across three domains.
Adaptive Capacity reflects the ability to cope with and adjust to stressors, including access to resources, livelihood diversity, and social support.
Sensitivity captures the degree to which households are affected by shocks, based on their wellbeing, health, food and water security, and environmental conditions.
Exposure measures the extent to which households experience environmental and socio-economic shocks that threaten livelihoods.
The score ranges from 0 to 1, with higher values indicating greater household vulnerability.
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At baseline and endline (12 month)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Segurança alimentar
Prazo: No momento inicial e final (12 meses)
|
A segurança alimentar será avaliada através da Escala de Insegurança Alimentar no Acesso Domiciliar (HFIAS, na sigla em inglês), desenvolvida pelo projeto de Assistência Técnica em Alimentação e Nutrição (FANTA, na sigla em inglês).
A HFIAS é uma ferramenta padronizada que mede o acesso das famílias aos alimentos nas últimas quatro semanas, gerando uma pontuação contínua (intervalo: 0-27), em que pontuações mais altas indicam maior insegurança alimentar
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No momento inicial e final (12 meses)
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Mental Health
Prazo: At baseline and endline (12 month)
|
Mental health and psychological resilience will be accessed by Psychological Trauma index focused on post-traumatic stressful symptoms following climate related shocks. Mental health and psychological resilience will be assessed using the Psychological Trauma Index, a structured questionnaire measuring post-traumatic stress symptoms following climate related shocks. The index includes six items covering intrusive memories, emotional distress, avoidance, social withdrawal, irritability, and concentration difficulties. Each item is scored on a 5-point Likert scale (1 = Not at all, 5 = Very Frequently). Total scores range from 6 to 30, with higher scores indicating worse outcomes (greater severity of trauma symptoms). Lower scores reflect fewer symptoms and better psychological resilience. |
At baseline and endline (12 month)
|
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Household dietary diversity
Prazo: At baseline and endline (12 month)
|
Dietary diversity will be measured using the Household Dietary Diversity Score (HDDS), following FAO guidelines. The HDDS is based on a 24 hour recall of foods consumed from 12 standard food groups (cereals, roots/tubers, vegetables, fruits, meat, eggs, fish, legumes/nuts, milk/dairy, oils/fats, sugar/honey, and miscellaneous). Scores on the Household Dietary Diversity Score range from 0 to 12, with higher values indicating better outcomes (greater dietary diversity and improved household food access). A score of 0 reflects no food group consumption in the recall period, while a score of 12 reflects consumption from all food groups. |
At baseline and endline (12 month)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Financial Literacy
Prazo: At baseline and endline (12 month)
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Financial literacy will be assessed through structured survey questions on access to financial services (e.g., household members with bank accounts), insurance coverage, savings and borrowing practices, bill payment regularity, expense planning, and ability to meet emergency needs.
Outcomes will be reported as individual indicators (counts and proportions)
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At baseline and endline (12 month)
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Household Disaster Preparedness
Prazo: At baseline and endline (12 month)
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Household disaster preparedness will be assessed through structured survey questions covering awareness of disaster management, integration of preparedness knowledge into household plans, availability of emergency supplies, evacuation knowledge, prior preparedness actions, and exposure to community training or organizations involved in disaster response.
Outcomes will be reported as individual indicators (counts and proportions)
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At baseline and endline (12 month)
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Health Knowledge and Practices
Prazo: At baseline and endline (12 month)
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Health knowledge and practices will be assessed using a structured questionnaire evaluating knowledge and reported practices related to climate-sensitive health risks.
Responses will be summarized at the item level as counts and proportions.
No composite score or scale will be generated for this outcome; results will be presented as individual indicators.
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At baseline and endline (12 month)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Palavras-chave
Outros números de identificação do estudo
- 2026-12334-39680
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Descrição do plano IPD
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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