Clinical trial NCT02158741: Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes
Official title: A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
NIDDM
Non-insulin Dependent Diabetes Mellitus
Keywords: Self-Management
Home Visits
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-06-09
Enrollment: 291
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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

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?

Eligibility criteria: 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).

Primary outcomes:
measure: Summary of Diabetes Self-Care Activities
timeFrame: Every two months from study onset until the end of study (6 months from baseline)
Secondary outcomes:
measure: SF12v2
timeFrame: Baseline and end of study (6 months from baseline)
Other outcomes:
measure: CES-D-10
timeFrame: Baseline and end of study (6 months from baseline)
measure: GAD-7
timeFrame: Baseline and end of study (6 months from baseline)
measure: Health Assessment forms
timeFrame: Baseline intervention interview, at 3 months and again at 6 months
Locations:
city: Edmonton
country: Canada
facility: Edmonton Oliver PCN
state: Alberta
city: Leduc
country: Canada
facility: Leduc Beaumont Devon PCN
state: Alberta
city: Sherwood Park
country: Canada
facility: Sherwood Park PCN
state: Alberta
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Lindsay
country: Canada
facility: Ross Memorial Hospital
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
city: Peterborough
country: Canada
facility: Peterborough Regional Health Centre
state: Ontario
city: Port Hope
country: Canada
facility: Port Hope Community Health Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen Markle-Reid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Jenny Ploeg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.