Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes
NCT ID: NCT02158741
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
291 participants
INTERVENTIONAL
2014-09-30
2017-05-31
Brief Summary
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Detailed Description
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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
1. To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services?
2. 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?
3. To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care?
4. To assess whether or not the intervention improves clinical practice behaviours?
5. To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective?
6. To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention?
7. To determine the effectiveness of the intervention based on sex/gender and region?
8. 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?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Usual Primary Care
Usual Primary Care will be received by half the participants during the course of the Study
No interventions assigned to this group
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.
Home Visits and Lifestyle Education Support
Interventions
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Home Visits and Lifestyle Education Support
Eligibility Criteria
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Inclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Ontario Ministry of Health and Long Term Care
OTHER_GOV
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
McMaster University
OTHER
Responsible Party
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Maureen Markle-Reid
RN, PhD, Scientific Director
Principal Investigators
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Maureen Markle-Reid, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Jenny Ploeg, PhD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Edmonton Oliver PCN
Edmonton, Alberta, Canada
Leduc Beaumont Devon PCN
Leduc, Alberta, Canada
Sherwood Park PCN
Sherwood Park, Alberta, Canada
McMaster University
Hamilton, Ontario, Canada
Ross Memorial Hospital
Lindsay, Ontario, Canada
St. Joseph's Health Care
London, Ontario, Canada
Peterborough Regional Health Centre
Peterborough, Ontario, Canada
Port Hope Community Health Centre
Port Hope, Ontario, Canada
Countries
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References
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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, 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, 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.
Other Identifiers
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DRCT-06669
Identifier Type: -
Identifier Source: org_study_id
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