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Completed

NCT Number: NCT01880476

Interprofessional Community-Based Diabetes Intervention for Older Adults

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home visits and group program

Other

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Diabetes Care Guelph
  • Guelph Wellington Seniors Association

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 19, 2013
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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