- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Akber Ali, Masters
- Telefonní číslo: +92-307-777-1403
- E-mail: akber.ali@aku.edu
Studijní záloha kontaktů
- Jméno: Dr. Jai Kumar Das, PhD
- Telefonní číslo: 0213486 69826
- E-mail: jai.das@aku.edu
Studijní místa
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Sindh
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Karachi, Sindh, Pákistán
- Aga Khan University
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Kontakt:
- Akber Ali, Masters
- Telefonní číslo: +92-307-777-1403
- E-mail: akber.ali@aku.edu
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Kontakt:
- Dr. Jai Kumar Das, PhD
- Telefonní číslo: 0213486 69826
- E-mail: jai.das@aku.edu
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Vrchní vyšetřovatel:
- Dr. Jai Das, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Komunitní intervence (CI)
Klastry dostávají strukturovaný balík komunitou vedených adaptačních a odolnostních intervencí realizovaných prostřednictvím Vesnických řídících výborů (VMCs).
Činnosti zahrnují školení a participativní sezení zaměřená na snižování rizika katastrof, diverzifikaci obživy, finanční gramotnost a zdravotní povědomí.
Sezení probíhají pomocí participativních učebních přístupů k posílení adaptační kapacity domácností a komunit.
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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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Experimentální: Komunitní + Intervence primární zdravotní péče (CHI)
Shluky dostávají stejné komunitní intervence jako Rameno 1, s dodatečným zapojením Lady Health Workers a poskytovatelů primární zdravotní péče.
Aktéři zdravotního systému podporují poskytování zdravotních složek, podporují vyhledávání péče a posilují vazby mezi komunitami a zdravotnickými službami za účelem zvýšení odolnosti.
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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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Žádný zásah: Kontrola
Shluky nedostávají během studijního období žádnou další intervenci kromě stávajících služeb a standardních podmínek.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Household disaster resilience
Časové okno: At baseline and endline (12 month)
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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
Časové okno: 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)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Potravinové zabezpečení
Časové okno: Na začátku a na konci (12 měsíců)
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Potravinové zabezpečení bude hodnoceno pomocí Chicagské škály nejistoty přístupu k potravinám (HFIAS), vyvinuté projektem Food and Nutrition Technical Assistance (FANTA).
HFIAS je standardizovaný nástroj, který měří přístup domácnosti k potravinám za poslední čtyři týdny a generuje spojité skóre (rozmezí: 0–27), přičemž vyšší skóre značí větší potravinovou nejistotu.
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Na začátku a na konci (12 měsíců)
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Mental Health
Časové okno: At baseline and endline (12 month)
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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
Časové okno: At baseline and endline (12 month)
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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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Financial Literacy
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 2026-12334-39680
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