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Completed

NCT Number: NCT02158741

Comparison Study of Usual Care vs. Usual Care Plus Community Intervention to Manage Type 2 Diabetes

The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers. Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases NIDDM Non-Insulin Dependent Diabetes Mellitus Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edmonton Oliver PCN, Edmonton, Alberta, Canada

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About this study

Research Goal

To examine the comparative effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with T2DM and Multiple Chronic Conditions and their family caregivers.

Objectives

  • To determine if a 6-month, IP, community-based intervention improve self-management compared with usual primary care services?
  • To compare the effectiveness of the intervention on HRQoL, physical activity, nutritional status, depression, anxiety, diabetes parameters (blood glucose levels [HbA1c, hypoglycemic episodes]), diabetes-related complications, number of vascular events, social support number of falls, fall risk and medication safety with usual primary care services?
  • To determine the effectiveness of the intervention on HRQoL of family caregivers compared with usual primary care?
  • To assess whether or not the intervention improves clinical practice behaviours?
  • To determine the 6-month costs of use of health services of the intervention compared with usual care, from a social perspective?
  • To identify which subgroups of older adults with T2DM and MCC benefit most from the intervention?
  • To determine the effectiveness of the intervention based on sex/gender and region?
  • To determine the overall feasibility and acceptability of an IP community-based health promotion intervention and what can be identified as barriers and facilitators to implementation?

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • older adults aged 65+
  • live in the local vicinity of a participating Diabetes Education Program
  • were referred to their Diabetes Education Program within the past 24 months
  • competence in English (or access to a translator)
  • intention to continue living in the area for the next 6 months
  • two reported chronic conditions in addition to T2DM. Individuals with newly diagnosed T2DM as well as those who were already receiving treatment for T2DM will be eligible for inclusion in the study.

Exclusion criteria

  • score of 20 or less in Montreal Cognitive Assessment (MoCA) test AND without access to a substitute decision maker to sign consent (Score of 20 or less is not in itself an exclusion).

Treatment and study plan

Home Visits and Lifestyle Education Support

Behavioral

Primary outcomes

  1. Summary of Diabetes Self-Care Activities

    Time frame: Every two months from study onset until the end of study (6 months from baseline)

    The SDSCA is a multidimensional measure of diabetes self-management with adequate internal and test-retest reliability, and evidence of validity and sensitivity to change. The revised SDSCA consists of items that assess the following aspects of the diabetes regimen: general and specific diet, exercise, blood-glucose testing, foot care, and smoking. Scores are calculated for each of these five regimen areas. This data is collected by the interventionists at each visit.

Secondary outcomes

  1. SF12v2

    Time frame: Baseline and end of study (6 months from baseline)

    This measurement is used to assess Health related quality of Life. This survey consists of 12 questions that measure functional health and well-being from the client's perspective. It provides scores for eight health domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health), and psychometrically-based physical component summary (PCS) and mental component summary (MCS) scores

Other outcomes

  1. CES-D-10

    Time frame: Baseline and end of study (6 months from baseline)

    The CES-D has been used in prior studies of older adults with mood disorders, and has a high degree of reliability, content, construct and criterion related validity, distinguishes between depressed and non-depressed people, and is a sensitive tool for measuring changes in depressive symptoms over time in psychiatric populations.

  2. GAD-7

    Time frame: Baseline and end of study (6 months from baseline)

    Prevalence and severity of anxiety, measured by the Generalized Anxiety Disorder Screener

  3. Health Assessment forms

    Time frame: Baseline intervention interview, at 3 months and again at 6 months

    • Diabetes parameters (fasting blood glucose, HbA1c, hypoglycemic episodes), and presence of diabetes-related complications and comorbid chronic conditions, obtained from health assessment forms submitted by the Diabetes Education Program RN and RD after the first home visit and at 3 months and 6 months.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Ontario Ministry of Health and Long Term Care

Registry information

Official study title

A Client-Driven Intervention to Support Self-Management Among Community-Living Older Adults With Type 2 Diabetes and Multiple Chronic Conditions

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2014
Registry last updated
Aug 30, 2019

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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