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

Sponsor

McMaster University (Other)

Overall Status

Completed

CT.gov ID

NCT02158741

Collaborator

Ontario Ministry of Health and Long Term Care (Other), Canadian Institutes of Health Research (CIHR) (Other)

291

Enrollment

Locations

Arms

Duration (Months)

36.4

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus NIDDM Non-insulin Dependent Diabetes Mellitus	Behavioral: Home Visits and Lifestyle Education Support	N/A

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

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?

Study Design

Study Type:

Interventional

Actual Enrollment :

291 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

May 1, 2017

Actual Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Primary Care Usual Primary Care will be received by half the participants during the course of the Study
Active Comparator: 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.	Behavioral: Home Visits and Lifestyle Education Support

Arm

Intervention/Treatment

No Intervention: Usual Primary Care

Usual Primary Care will be received by half the participants during the course of the Study

Active Comparator: 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.

Behavioral: Home Visits and Lifestyle Education Support

Outcome Measures

Primary Outcome Measures

Summary of Diabetes Self-Care Activities [Every two months from study onset until the end of study (6 months from baseline)]
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.

Secondary Outcome Measures

SF12v2 [Baseline and end of study (6 months from baseline)]
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

Other Outcome Measures

CES-D-10 [Baseline and end of study (6 months from baseline)]
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.
GAD-7 [Baseline and end of study (6 months from baseline)]
Prevalence and severity of anxiety, measured by the Generalized Anxiety Disorder Screener
Health Assessment forms [Baseline intervention interview, at 3 months and again at 6 months]
• 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Edmonton Oliver PCN	Edmonton	Alberta	Canada
2	Leduc Beaumont Devon PCN	Leduc	Alberta	Canada	T9E 6W2
3	Sherwood Park PCN	Sherwood Park	Alberta	Canada
4	McMaster University	Hamilton	Ontario	Canada	L8S 4K1
5	Ross Memorial Hospital	Lindsay	Ontario	Canada
6	St. Joseph's Health Care	London	Ontario	Canada
7	Peterborough Regional Health Centre	Peterborough	Ontario	Canada
8	Port Hope Community Health Centre	Port Hope	Ontario	Canada