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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
Sponsor:
Collaborators:
Diabetes Care Guelph
Guelph Wellington Seniors Association
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Home visits and group program Not Applicable

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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


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

Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Diabetes Care Guelph
Guelph Wellington Seniors Association
Investigators
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Principal Investigator: Maureen Markle-Reid, PhD, RN McMaster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT01880476    
Other Study ID Numbers: Labarge-13-377
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Keywords provided by McMaster University:
Diabetes Mellitus, Type 2
Comorbidity
Aged
Health Services
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases