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Clinical Trials/NCT01880476
NCT01880476CompletedNot Applicable

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

McMaster University1 site in 1 country45 target enrollmentStarted: June 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Changes from baseline in the Summary of Diabetes Self-Care Activities questionnaire

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • Not provided

Arms & Interventions

Home visits and group program

Experimental

Intervention: Home visits and group program (Other)

Outcomes

Primary Outcomes

Changes from baseline in the Summary of Diabetes Self-Care Activities questionnaire

Time Frame: baseline and 6 months

This questionnaire measures self-care activities including diet, exercise, blood glucose testing, foot care, and smoking.

Secondary Outcomes

  • Changes from baseline in HbA1C (%)(Baseline and 6 months)
  • Changes from baseline in symptoms of anxiety (Generalized Anxiety Disorder Screener-7 Scale)(Baseline and 6 months)
  • Changes from baseline in costs of use of health services (Health and Social Services Utilization Inventory)(Baseline and 6 months)
  • Changes from baseline in health-related quality of life (SF-12v2 health survey)(Baseline and 6 months)
  • Changes from baseline in depressive symptoms (Centre for Epidemiological Studies Depression Scale)(Baseline and 6 months)
  • Changes from baseline in number of hypoglycemic events per week (blood glucose <4.0 mmol/L)(Baseline and 6 months)
  • Changes from baseline in fasting blood glucose (mmol/L)(Baseline and 6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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