Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04272099
Status:
UNKNOWN
Last Update Posted:
2022-10-24
First Post:
2020-02-13
Brief Title:
Social Determinants of Global Pediatric Diabetes
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Individual and Social Determinants of Health in Global Pediatric Diabetes Care Delivery - a Participatory Search for Barriers and Opportunities
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DESIDE
Brief Summary:
There is little data from low-income countries on setting and culture specific perception of childhood diabetes and disease specific stressors including stigma and how these may affect disease related quality of life coping strategies self-efficacy and glycemic control
The goal of this study is to understand how socioeconomic psychosocial cultural and diet and activity related factors in children and adolescents with diabetes in Haiti relate to quality of life self-efficacy and glycemic control and comparing the factor analysis to immigrant children of Haitian ancestry with diabetes living in Montreal
An innovative participatory research approach will allow for a holistic evaluation of modifiable barriers to optimal pediatric diabetes care delivery in resource limited settings while providing translational information for care delivery of diabetes in underserved immigrant populations in high-income settings
The goal of this study is to understand how socioeconomic psychosocial cultural and diet and activity related factors in children and adolescents with diabetes in Haiti relate to quality of life self-efficacy and glycemic control and comparing the factor analysis to immigrant children of Haitian ancestry with diabetes living in Montreal
An innovative participatory research approach will allow for a holistic evaluation of modifiable barriers to optimal pediatric diabetes care delivery in resource limited settings while providing translational information for care delivery of diabetes in underserved immigrant populations in high-income settings
Detailed Description:
Pediatric diabetes is a lifelong condition that affects an estimated 542000 children under the age of 14 years worldwide of whom the majority live in low- and middle-income countries Epidemiological data from Haiti on the incidence and prevalence of diabetes in childhood are currently being collected In Haiti as in many other low-income countries there is likely to be incomplete case ascertainment due to a lack of accurate and timely diagnosis The investigators group as well as others have observed remarkable differences in clinical presentation of childhood diabetes as compared to Caucasian patients Presentations reminiscent of atypical diabetes fibrocalculous pancreatitis and malnutrition related diabetes seem to be more frequent Many patients retain low exogenous insulin requirements past 5-10 years after initial diagnosis suggesting much longer periods of residual endogenous insulin production as compared to Caucasian patients Further while complications of diabetes are considered a rarity in Caucasian patients up to 20 of Haitian children and adolescents presenting with diabetes have eye complications cataract andor retinopathy at the time of or within 2-3 years of diagnosis unpublished data Although genetic environmental and immune factors have been hypothesized the investigators do not currently understand the underlying etiology of these unusual phenotypes and how those relate to glycemic control
Limited data from sites in low-income countries where pediatric diabetes care has been established including from Haiti concerningly show that even when patients are regularly followed and insulin and diabetes care supplies are provided free of charge glycemic control remains suboptimal While psychosocial sociocultural educational and economic factors including diet habits and food insecurity are known to be associated with glycemic control detailed evaluations from low-income countries on these factors and how they related to diabetes management in children are lacking Similarly there is little data from low-income countries on setting and culture specific perception of childhood diabetes and disease specific stressors including stigma and how these may affect disease related quality of life coping strategies self-efficacy and glycemic control
Child and parent health literacy defined as the degree to which individuals have the capacity to obtain process and understand basic health information and services needed to make appropriate health decisions has been shown to impact diabetes self-efficacy including improved diabetes management and glycemic control However little is known about health literacy in children with diabetes and their families in resource limited settings and its effect on diabetes care has not been evaluated in Haiti The degree to which these complex interrelated and dynamic factors affect long-term outcomes is not known
Lastly community family and peer support is known to impact health outcomes in children with chronic disease However in many resource limited settings local support groups are not available or are only offered at the diabetes clinic which can be remote from the patients home many patients travel several hours to get to the diabetes clinic It is unknown if the use of social networks for patients with diabetes in resource limited settings can improve perceived and objective health related outcomes
The specific aims of this research project are
1 To evaluate the socioeconomic status SES of children with diabetes and their families in Haiti and of Haitian immigrant children with diabetes in Montreal
2 To conduct a detailed psychosocial evaluation of participating children
3 To analyze macro- and micronutrient intake dietary patterns food security and physical activity patterns in participating children
4 To investigate perceptions and explanations of illness and health and to assess health literacy and diabetes self-efficacy in participating children and caregivers
5 To evaluate how SES psychosocial well-being illness perception health literally self-efficacy and lifestyle habits relate to glycemic control and quality of life and clinical phenotypes
The investigators will also assess how results compare between the two study sites
Limited data from sites in low-income countries where pediatric diabetes care has been established including from Haiti concerningly show that even when patients are regularly followed and insulin and diabetes care supplies are provided free of charge glycemic control remains suboptimal While psychosocial sociocultural educational and economic factors including diet habits and food insecurity are known to be associated with glycemic control detailed evaluations from low-income countries on these factors and how they related to diabetes management in children are lacking Similarly there is little data from low-income countries on setting and culture specific perception of childhood diabetes and disease specific stressors including stigma and how these may affect disease related quality of life coping strategies self-efficacy and glycemic control
Child and parent health literacy defined as the degree to which individuals have the capacity to obtain process and understand basic health information and services needed to make appropriate health decisions has been shown to impact diabetes self-efficacy including improved diabetes management and glycemic control However little is known about health literacy in children with diabetes and their families in resource limited settings and its effect on diabetes care has not been evaluated in Haiti The degree to which these complex interrelated and dynamic factors affect long-term outcomes is not known
Lastly community family and peer support is known to impact health outcomes in children with chronic disease However in many resource limited settings local support groups are not available or are only offered at the diabetes clinic which can be remote from the patients home many patients travel several hours to get to the diabetes clinic It is unknown if the use of social networks for patients with diabetes in resource limited settings can improve perceived and objective health related outcomes
The specific aims of this research project are
1 To evaluate the socioeconomic status SES of children with diabetes and their families in Haiti and of Haitian immigrant children with diabetes in Montreal
2 To conduct a detailed psychosocial evaluation of participating children
3 To analyze macro- and micronutrient intake dietary patterns food security and physical activity patterns in participating children
4 To investigate perceptions and explanations of illness and health and to assess health literacy and diabetes self-efficacy in participating children and caregivers
5 To evaluate how SES psychosocial well-being illness perception health literally self-efficacy and lifestyle habits relate to glycemic control and quality of life and clinical phenotypes
The investigators will also assess how results compare between the two study sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None