Interprofessional Community-Based Diabetes Intervention for Older Adults

July 6, 2016 updated by: McMaster University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home visits and group program
Other: Home visits and group program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partnership and collaboration questionnaire
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Diabetes Care Guelph
Guelph Wellington Seniors Association

Investigators

  • Principal Investigator: Maureen Markle-Reid, PhD, RN, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 14, 2013

First Posted (Estimate)

June 19, 2013

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 6, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Labarge-13-377

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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