Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158741
• Other study ID #: DRCT-06669
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: May 2017

Study information

• Verified date: August 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• NIDDM
• Non-insulin Dependent Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Home Visits and Lifestyle Education Support

Locations

Country	Name	City	State
Canada	Edmonton Oliver PCN	Edmonton	Alberta
Canada	McMaster University	Hamilton	Ontario
Canada	Leduc Beaumont Devon PCN	Leduc	Alberta
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	Sherwood Park PCN	Sherwood Park	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CES-D-10	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.	Baseline and end of study (6 months from baseline)
Other	GAD-7	Prevalence and severity of anxiety, measured by the Generalized Anxiety Disorder Screener	Baseline and end of study (6 months from baseline)
Other	Health Assessment forms	• 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.	Baseline intervention interview, at 3 months and again at 6 months
Primary	Summary of Diabetes Self-Care Activities	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.	Every two months from study onset until the end of study (6 months from baseline)
Secondary	SF12v2	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	Baseline and end of study (6 months from baseline)

External Links

•   Aging, Community and Health Research Unit