Interprofessional Community-Based Diabetes Intervention for Older Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01880476|
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : July 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Other: Home visits and group program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|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 Start Date :||June 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|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.
- 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.
- Changes from baseline in health-related quality of life (SF-12v2 health survey) [ Time Frame: Baseline and 6 months ]
- Changes from baseline in depressive symptoms (Centre for Epidemiological Studies Depression Scale) [ Time Frame: Baseline and 6 months ]
- Changes from baseline in symptoms of anxiety (Generalized Anxiety Disorder Screener-7 Scale) [ Time Frame: 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 ]
- Changes from baseline in fasting blood glucose (mmol/L) [ Time Frame: Baseline and 6 months ]
- Changes from baseline in HbA1C (%) [ Time Frame: 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 ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880476
|Hamilton, Ontario, Canada, L8S 4K1|
|Principal Investigator:||Maureen Markle-Reid, PhD, RN||McMaster University|