An observational study in Diabetes Mellitus, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Status unknown at 4 sites in 2 countries. Open to participants aged 0 Years to 25 Years. Per ClinicalTrials.gov, last updated 2022-10-24.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
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.
Pediatric diabetes is a lifelong condition that affects an estimated 542,000 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 and/or 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 patient's 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:
The investigators will also assess how results compare between the two study sites.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 79 is below the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
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The study will take place at 2 sites:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients 0 to 25 years of age, with a diagnosis of diabetes that are either followed at Kay Mackenson Pediatric Clinic, Haiti, or who are of Haitian ancestry, defined as both maternal and paternal grandparents being born in Haiti, and attend one of the three diabetes clinics in Montreal.
Other: Administration of standardized questionnaires · Device: Physical activity tracker · Other: Dietary log
The patient's principal caregiver (a parent of legal guardian).
Other: Administration of standardized questionnaires
Administration of questionnaires assessing subjective socioeconomic status (SES), health literacy, perceived health, health related quality of life, self-esteem and diabetes self-efficacy
PG1 will be asked to wear a physical activity tracker for one week to monitor activity patterns including walking distance, calorie expenditure, sedentary time and sleep.
PG1 (or PG2 as proxies when appropriate) will report to a study coordinator via phone a full dietary log of PG1 once per week on rotating days of the week for three weeks.
Socioeconomic status, health literacy level, and diabetes self-efficacy in PG1 and PG2
ZIP code-based SES indicators and questionnaires on health literacy, and diabetes self-efficacy
Time frame: These variables will be assessed cross-sectionally at time of enrolment
The psychosocial and physical health status of PG1
Questionnaires on perceived health, health-related quality of life, and self-esteem
Time frame: These variables will be assessed cross-sectionally at time of enrolment
Diet and activity related lifestyle habits of children with diabetes of PG1
Collection of data on dietary composition, meal distribution pattern, and activity patterns including walking distance, calorie expenditure, sedentary time and sleep.
Time frame: These variables will be assessed prospectively over three months during follow-up from time of enrolment
Glycemic control, health related quality of life and clinical phenotypes of PG1
Extraction of clinical records, data on the date of diagnosis, clinical presentation at diagnosis, hemoglobin A1C measurements over time, most recent weight, height, body mass index (BMI) and total daily insulin dose. Questionnaire on health-related quality of life. Data collection on blood glucose monitoring frequency and distribution, blood glucose values, as well as insulin dosing and injections.
Time frame: Retrospective data from time of diagnosis, cross-sectional at time of enrolment and prospective monitoring over three months from time of diabetes diagnosis and over three months from time of enrolment
Psychometric evaluation of the health literacy, health-related quality of life, self-esteem and self-efficacy questionnaires in PG1
Standardized questionnaires
Time frame: Cross-sectional assessment at time of enrolment
Plan to share: No
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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McGill University Health Centre/Research Institute of the McGill University Health Centre →