Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes
28 de agosto de 2019 atualizado por: Maureen Markle-Reid, McMaster University
A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions
The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers.
Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
Research Goal
To examine the comparative effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with T2DM and Multiple Chronic Conditions and their family caregivers.
Objectives
- To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services?
- To compare the effectiveness of the intervention on HRQoL, physical activity, nutritional status, depression, anxiety, diabetes parameters (blood glucose levels [HbA1c, hypoglycemic episodes]), diabetes-related complications, number of vascular events, social support number of falls, fall risk and medication safety with usual primary care services?
- To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care?
- To assess whether or not the intervention improves clinical practice behaviours?
- To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective?
- To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention?
- To determine the effectiveness of the intervention based on sex/gender and region?
- To determine the overall feasibility and acceptability of an IP community-based health promotion intervention and what can be identified as barriers and facilitators to implementation?
Tipo de estudo
Intervencional
Inscrição (Real)
291
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Alberta
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Edmonton, Alberta, Canadá
- Edmonton Oliver PCN
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Leduc, Alberta, Canadá, T9E 6W2
- Leduc Beaumont Devon PCN
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Sherwood Park, Alberta, Canadá
- Sherwood Park PCN
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Ontario
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Hamilton, Ontario, Canadá, L8S 4K1
- McMaster University
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Lindsay, Ontario, Canadá
- Ross Memorial Hospital
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London, Ontario, Canadá
- St. Joseph's Health Care
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Peterborough, Ontario, Canadá
- Peterborough Regional Health Centre
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Port Hope, Ontario, Canadá
- Port Hope Community Health Centre
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
65 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- older adults aged 65+
- live in the local vicinity of a participating Diabetes Education Program
- were referred to their Diabetes Education Program within the past 24 months
- competence in English (or access to a translator)
- intention to continue living in the area for the next 6 months
- two reported chronic conditions in addition to T2DM. Individuals with newly diagnosed T2DM as well as those who were already receiving treatment for T2DM will be eligible for inclusion in the study.
Exclusion Criteria:
- score of 20 or less in Montreal Cognitive Assessment (MoCA) test AND without access to a substitute decision maker to sign consent (Score of 20 or less is not in itself an exclusion).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
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 |
|---|---|
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Sem intervenção: Usual Primary Care
Usual Primary Care will be received by half the participants during the course of the Study
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Comparador Ativo: Home Visits and educational support
Intervention comprised of Home Visits and group educational sessions.
Home Visits and will be conducted by Diabetes Education staff in lieu of usual care conducted at the Diabetes clinic.
Lifestyle support and educational will be offered in the form of monthly Diabetes Wellness Days offered in the community where nutrition, exercise and support will be given to help improve self-management of diabetes.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Summary of Diabetes Self-Care Activities
Prazo: Every two months from study onset until the end of study (6 months from baseline)
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The SDSCA is a multidimensional measure of diabetes self-management with adequate internal and test-retest reliability, and evidence of validity and sensitivity to change.
The revised SDSCA consists of items that assess the following aspects of the diabetes regimen: general and specific diet, exercise, blood-glucose testing, foot care, and smoking.
Scores are calculated for each of these five regimen areas.
This data is collected by the interventionists at each visit.
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Every two months from study onset until the end of study (6 months from baseline)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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SF12v2
Prazo: Baseline and end of study (6 months from baseline)
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This measurement is used to assess Health related quality of Life.
This survey consists of 12 questions that measure functional health and well-being from the client's perspective.
It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health), and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores
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Baseline and end of study (6 months from baseline)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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CES-D-10
Prazo: Baseline and end of study (6 months from baseline)
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The CES-D has been used in prior studies of older adults with mood disorders, and has a high degree of reliability, content, construct and criterion related validity, distinguishes between depressed and non-depressed people, and is a sensitive tool for measuring changes in depressive symptoms over time in psychiatric populations.
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Baseline and end of study (6 months from baseline)
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GAD-7
Prazo: Baseline and end of study (6 months from baseline)
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Prevalence and severity of anxiety, measured by the Generalized Anxiety Disorder Screener
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Baseline and end of study (6 months from baseline)
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Health Assessment forms
Prazo: Baseline intervention interview, at 3 months and again at 6 months
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• Diabetes parameters (fasting blood glucose, HbA1c, hypoglycemic episodes), and presence of diabetes-related complications and comorbid chronic conditions, obtained from health assessment forms submitted by the Diabetes Education Program RN and RD after the first home visit and at 3 months and 6 months.
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Baseline intervention interview, at 3 months and again at 6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maureen Markle-Reid, PhD, McMaster University
- Investigador principal: Jenny Ploeg, PhD, McMaster University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Markle-Reid M, Ploeg J, Valaitis R, Duggleby W, Fisher K, Fraser K, Ganann R, Griffith LE, Gruneir A, McAiney C, Williams A. Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. J Comorb. 2018 Jul 31;8(1):2235042X18789508. doi: 10.1177/2235042X18789508. eCollection 2018.
- Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Bartholomew A, Griffith LE, Miklavcic J, Gafni A, Thabane L, Upshur R. Community Program Improves Quality of Life and Self-Management in Older Adults with Diabetes Mellitus and Comorbidity. J Am Geriatr Soc. 2018 Feb;66(2):263-273. doi: 10.1111/jgs.15173. Epub 2017 Nov 27.
- Miklavcic JJ, Fraser KD, Ploeg J, Markle-Reid M, Fisher K, Gafni A, Griffith LE, Hirst S, Sadowski CA, Thabane L, Triscott JAC, Upshur R. Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial. BMC Geriatr. 2020 May 13;20(1):174. doi: 10.1186/s12877-020-01557-0.
- Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Akhtar-Danesh N, Bartholomew A, Gafni A, Gruneir A, Hirst SP, Kaasalainen S, Stradiotto CK, Miklavcic J, Rojas-Fernandez C, Sadowski CA, Thabane L, Triscott JA, Upshur R. The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):55. doi: 10.1186/s13063-017-1795-9.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2014
Conclusão Primária (Real)
1 de maio de 2017
Conclusão do estudo (Real)
1 de maio de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
3 de junho de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de junho de 2014
Primeira postagem (Estimativa)
9 de junho de 2014
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de agosto de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de agosto de 2019
Última verificação
1 de agosto de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DRCT-06669
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Ensaios clínicos em Home Visits and Lifestyle Education Support
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Psychiatric Research Unit, Region Zealand, DenmarkRetiradoInternação Psiquiátrica