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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by McMaster University
Sponsor:
Collaborators:
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Maureen Markle-Reid, McMaster University
ClinicalTrials.gov Identifier:
NCT02158741
First received: June 3, 2014
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
NIDDM
Non-insulin Dependent Diabetes Mellitus
Behavioral: Home Visits and Lifestyle Education Support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Summary of Diabetes Self-Care Activities [ Time Frame: Every two months from study onset until the end of study (6 months from baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and end of study (6 months from baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and end of study (6 months from baseline) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and end of study (6 months from baseline) ] [ Designated as safety issue: No ]
    Prevalence and severity of anxiety, measured by the Generalized Anxiety Disorder Screener

  • Health Assessment forms [ Time Frame: Baseline intervention interview, at 3 months and again at 6 months ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 160
Study Start Date: September 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02158741

Contacts
Contact: Amy Bartholomew, RN, BScN 905-525-9140 ext 20294 barthol@mcmaster.ca

Locations
Canada, Ontario
McMaster University Not yet recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Amy Bartholomew, RN, BScN    905-525-9140 ext 20294    barthol@mcmaster.ca   
Principal Investigator: Maureen Markle-Reid, PhD         
Sub-Investigator: Jenny Ploeg, PhD         
Sponsors and Collaborators
McMaster University
Ontario Ministry of Health and Long Term Care
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Maureen Markle-Reid, PhD McMaster University
Principal Investigator: Ross Upshur, MD University of Toronto
  More Information

No publications provided

Responsible Party: Maureen Markle-Reid, RN, PhD, Scientific Director, McMaster University
ClinicalTrials.gov Identifier: NCT02158741     History of Changes
Other Study ID Numbers: DRCT-06669
Study First Received: June 3, 2014
Last Updated: June 6, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
Self-Management
Home Visits

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 20, 2014