NCT01880476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2.5 years

First QC Date

June 14, 2013

Last Update Submit

July 6, 2016

Conditions

Keywords

Diabetes Mellitus, Type 2ComorbidityAgedHealth Services

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • 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 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 fasting blood glucose (mmol/L)

    Baseline and 6 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Partnership and collaboration questionnaire

    6 months

Study Arms (1)

Home visits and group program

EXPERIMENTAL
Other: Home visits and group program

Interventions

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.

Home visits and group program

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

House Calls

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Maureen Markle-Reid, PhD, RN

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 19, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations