Interprofessional Community-Based Diabetes Intervention for Older Adults

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01880476
• Other study ID #: Labarge-13-377
• Status: Completed
• Phase: N/A
• First received: June 14, 2013
• Last updated: July 6, 2016
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Diabetes Care Guelph, Guelph Wellington Seniors Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Partnership and collaboration questionnaire	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	No
Primary	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.	baseline and 6 months	No
Secondary	Changes from baseline in health-related quality of life (SF-12v2 health survey)		Baseline and 6 months	No
Secondary	Changes from baseline in depressive symptoms (Centre for Epidemiological Studies Depression Scale)		Baseline and 6 months	No
Secondary	Changes from baseline in symptoms of anxiety (Generalized Anxiety Disorder Screener-7 Scale)		Baseline and 6 months	No
Secondary	Changes from baseline in costs of use of health services (Health and Social Services Utilization Inventory)		Baseline and 6 months	No
Secondary	Changes from baseline in fasting blood glucose (mmol/L)		Baseline and 6 months	No
Secondary	Changes from baseline in HbA1C (%)		Baseline and 6 months	No
Secondary	Changes from baseline in number of hypoglycemic events per week (blood glucose <4.0 mmol/L)		Baseline and 6 months	No