Interprofessional Community-Based Diabetes Intervention for Older Adults
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Home visits and group program
Sponsored by

About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, Comorbidity, Aged, Health Services
Eligibility Criteria
Inclusion Criteria:
- Age 65+
- Referred to Diabetes Care Guelph within the past 12 months
- At least two chronic conditions in addition to Type 2 Diabetes Mellitus
- English speaking
- Community-dwelling, in the city of Guelph
- Independent in activities of daily living
- Mentally competent to provide informed consent
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Home visits and group program
Arm Description
Outcomes
Primary Outcome Measures
Changes from baseline in the Summary of Diabetes Self-Care Activities questionnaire
This questionnaire measures self-care activities including diet, exercise, blood glucose testing, foot care, and smoking.
Secondary Outcome Measures
Changes from baseline in health-related quality of life (SF-12v2 health survey)
Changes from baseline in depressive symptoms (Centre for Epidemiological Studies Depression Scale)
Changes from baseline in symptoms of anxiety (Generalized Anxiety Disorder Screener-7 Scale)
Changes from baseline in costs of use of health services (Health and Social Services Utilization Inventory)
Changes from baseline in fasting blood glucose (mmol/L)
Changes from baseline in HbA1C (%)
Changes from baseline in number of hypoglycemic events per week (blood glucose <4.0 mmol/L)
Full Information
NCT ID
NCT01880476
First Posted
June 14, 2013
Last Updated
July 6, 2016
Sponsor
McMaster University
Collaborators
Diabetes Care Guelph, Guelph Wellington Seniors Association
1. Study Identification
Unique Protocol Identification Number
NCT01880476
Brief Title
Interprofessional Community-Based Diabetes Intervention for Older Adults
Official Title
Feasibility, Acceptability and Effects of an Interprofessional Community-Based Health Promotion Intervention on Self-Management in Older Adults With Type 2 Diabetes and Comorbid Chronic Conditions: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Diabetes Care Guelph, Guelph Wellington Seniors Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine the feasibility and acceptability of a 6-month interprofessional community-based health promotion program, and explore its effects on older adults' self-management of Type 2 Diabetes (T2DM). Recently enrolled clients of Diabetes Care Guelph (DCG), who are age 65+ and have at least two other chronic conditions, will be eligible to participate. Participants must be English speaking, community-dwelling, independent in activities of daily living, and mentally competent to give informed consent. The 6-month intervention will consist of: in-home visits by a Registered Nurse and Registered Dietitian from DCG; participation in a monthly Diabetes Wellness Day group program offered through the Guelph Wellington Seniors Association (GWSA) together with DCG; peer support from trained volunteers at the Diabetes Wellness Day group program; care coordination by the DCG Registered Nurse to help participants access necessary supports and services; and monthly team conferences between care providers at DCG and the GWSA to develop a client-centred plan of care. To evaluate the program, participants will complete interviewer-administered questionnaires before and after the intervention, and care providers and peer volunteers will take part in group interviews.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, Comorbidity, Aged, Health Services
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home visits and group program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Home visits and group program
Intervention Description
Participants will receive up to three home visits by a Registered Nurse and two home visits by a Registered Dietitian over the 6-month intervention period. Participants will also be invited to attend a monthly Diabetes Wellness Day group program which will include diabetes education, interaction with peer volunteers, group exercise, and a meal. The Registered Nurse will coordinate care to help participants access necessary community supports and services and lead monthly interprofessional case conferences to develop a client-centred plan of care for each study participant.
Primary Outcome Measure Information:
Title
Changes from baseline in the Summary of Diabetes Self-Care Activities questionnaire
Description
This questionnaire measures self-care activities including diet, exercise, blood glucose testing, foot care, and smoking.
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
Changes from baseline in health-related quality of life (SF-12v2 health survey)
Time Frame
Baseline and 6 months
Title
Changes from baseline in depressive symptoms (Centre for Epidemiological Studies Depression Scale)
Time Frame
Baseline and 6 months
Title
Changes from baseline in symptoms of anxiety (Generalized Anxiety Disorder Screener-7 Scale)
Time Frame
Baseline and 6 months
Title
Changes from baseline in costs of use of health services (Health and Social Services Utilization Inventory)
Time Frame
Baseline and 6 months
Title
Changes from baseline in fasting blood glucose (mmol/L)
Time Frame
Baseline and 6 months
Title
Changes from baseline in HbA1C (%)
Time Frame
Baseline and 6 months
Title
Changes from baseline in number of hypoglycemic events per week (blood glucose <4.0 mmol/L)
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Partnership and collaboration questionnaire
Description
This questionnaire will be completed by care providers who carry out the intervention. It will be used to help evaluate the feasibility and acceptability of the intervention.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 65+
Referred to Diabetes Care Guelph within the past 12 months
At least two chronic conditions in addition to Type 2 Diabetes Mellitus
English speaking
Community-dwelling, in the city of Guelph
Independent in activities of daily living
Mentally competent to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maureen Markle-Reid, PhD, RN
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
27965843
Citation
Markle-Reid M, Ploeg J, Fisher K, Reimer H, Kaasalainen S, Gafni A, Gruneir A, Kirkconnell R, Marzouk S, Akhtar-Danesh N, Thabane L, Rojas-Fernandez C, Upshur R. The Aging, Community and Health Research Unit-Community Partnership Program for older adults with type 2 diabetes and multiple chronic conditions: a feasibility study. Pilot Feasibility Stud. 2016 May 9;2:24. doi: 10.1186/s40814-016-0063-1. eCollection 2016.
Results Reference
derived
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Interprofessional Community-Based Diabetes Intervention for Older Adults
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