Clinical trial NCT01880476: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Comorbidity
Aged
Health Services
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Diabetes Care Guelph
name: Guelph Wellington Seniors Association
First posted: 2013-06-19
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Changes from baseline in the Summary of Diabetes Self-Care Activities questionnaire
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Changes from baseline in health-related quality of life (SF-12v2 health survey)
timeFrame: Baseline and 6 months
measure: Changes from baseline in depressive symptoms (Centre for Epidemiological Studies Depression Scale)
timeFrame: Baseline and 6 months
measure: Changes from baseline in symptoms of anxiety (Generalized Anxiety Disorder Screener-7 Scale)
timeFrame: Baseline and 6 months
measure: Changes from baseline in costs of use of health services (Health and Social Services Utilization Inventory)
timeFrame: Baseline and 6 months
measure: Changes from baseline in fasting blood glucose (mmol/L)
timeFrame: Baseline and 6 months
measure: Changes from baseline in HbA1C (%)
timeFrame: Baseline and 6 months
measure: Changes from baseline in number of hypoglycemic events per week (blood glucose <4.0 mmol/L)
timeFrame: Baseline and 6 months
Other outcomes:
measure: Partnership and collaboration questionnaire
timeFrame: 6 months
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Maureen Markle-Reid, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.