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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Home Visits and Lifestyle Education Support
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes Mellitus focused on measuring Self-Management, Home Visits

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Edmonton Oliver PCN
  • Leduc Beaumont Devon PCN
  • Sherwood Park PCN
  • McMaster University
  • Ross Memorial Hospital
  • St. Joseph's Health Care
  • Peterborough Regional Health Centre
  • Port Hope Community Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Primary Care

Home Visits and educational support

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2014
Last Updated
August 28, 2019
Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT02158741
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Ontario Ministry of Health and Long Term Care, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. 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.
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, NIDDM, Non-insulin Dependent Diabetes Mellitus
Keywords
Self-Management, Home Visits

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Primary Care
Arm Type
No Intervention
Arm Description
Usual Primary Care will be received by half the participants during the course of the Study
Arm Title
Home Visits and educational support
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home Visits and Lifestyle Education Support
Primary Outcome Measure Information:
Title
Summary of Diabetes Self-Care Activities
Description
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.
Time Frame
Every two months from study onset until the end of study (6 months from baseline)
Secondary Outcome Measure Information:
Title
SF12v2
Description
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
Time Frame
Baseline and end of study (6 months from baseline)
Other Pre-specified Outcome Measures:
Title
CES-D-10
Description
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.
Time Frame
Baseline and end of study (6 months from baseline)
Title
GAD-7
Description
Prevalence and severity of anxiety, measured by the Generalized Anxiety Disorder Screener
Time Frame
Baseline and end of study (6 months from baseline)
Title
Health Assessment forms
Description
• 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.
Time Frame
Baseline intervention interview, at 3 months and again at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Markle-Reid, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jenny Ploeg, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edmonton Oliver PCN
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Leduc Beaumont Devon PCN
City
Leduc
State/Province
Alberta
ZIP/Postal Code
T9E 6W2
Country
Canada
Facility Name
Sherwood Park PCN
City
Sherwood Park
State/Province
Alberta
Country
Canada
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Ross Memorial Hospital
City
Lindsay
State/Province
Ontario
Country
Canada
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
Country
Canada
Facility Name
Peterborough Regional Health Centre
City
Peterborough
State/Province
Ontario
Country
Canada
Facility Name
Port Hope Community Health Centre
City
Port Hope
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29178317
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.
Results Reference
result
PubMed Identifier
32404059
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.
Results Reference
derived
PubMed Identifier
30191144
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.
Results Reference
derived
PubMed Identifier
28166816
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.
Results Reference
derived

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

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