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Clinical Trials/NCT02209285
NCT02209285
Completed
Not Applicable

Self-Management Program for Older Adults With Multimorbidity: A Pragmatic Randomized Controlled Trial

McMaster University1 site in 1 country59 target enrollmentJanuary 2016
ConditionsMultimorbidity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multimorbidity
Sponsor
McMaster University
Enrollment
59
Locations
1
Primary Endpoint
Physical Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Patients with multimorbidity move between multiple care settings, and so they are at high risk of receiving fragmented care leading to increased risk for avoidable illness, death, and health care costs. Recent Canadian studies and reports identify significant gaps in the delivery of effective care to patients with multiple chronic conditions in community-based settings.

The overall goal of the intervention is to promote successful management of chronic conditions, enhance quality of life, reduce the on-demand use of expensive health services and support primary caregivers (i.e. family or friends) who provide physical, emotional or financial care to an older adult with multimorbidity. This research program will leverage the tremendous potential to reduce the burden of multimorbidity by enhancing community-based prevention and chronic disease management.

This pragmatic mixed-methods randomized controlled trial will evaluate the effectiveness of an interprofessional team-based self-management intervention on health-related quality of life (HRQOL), depression, anxiety, self-efficacy, and the costs of use of health services for older adults with multimorbidity receiving home care and their family caregivers. The results will inform: (1) the development of national standards for community-based care for patients with multimorbidity and (2) the development of a new and innovative community-based model for the management of multimorbidity that can be scaled up and spread across Canada.

Detailed Description

Research Question: What is the acceptability and effects of a six-month self-management program compared to usual home care services for older adults with multimorbidity and their family and friend caregivers? Methods: The design is a pragmatic, mixed-methods; randomized controlled trial with individuals newly referred to and using home care services. The intervention is a 6-month self-management program for older adults with multimorbidity. It will be provided by an interprofessional team of home care providers and will consist of three components: (1) intensive case management to facilitate access to services across the care continuum, provide psychosocial support and advocacy, and coordinate home care; (2) a minimum of two in-home visits by the Community Care Access Centre (CCAC) Case Manager, two visits by the Registered Nurse (RN), three visits by the Physiotherapist (PT) or Occupational Therapist (OT), and six visits by a Personal Support Worker (PSW) over 6 months in addition to usual home care services. The in-home visit schedule and team composition will be tailored to client needs and will be determined in collaboration with the home care providers. The interprofessional (IP) team will conduct comprehensive screening and assessments for chronic conditions, utilize strengths-based practice to encourage self-management and foster behavioural change, provide education for multimorbidity, medication review and management, in-home exercise, and caregiver support; and (3) monthly interprofessional team case conferences to develop an IP evidence-based, patient-centred care plan. Outcomes will be assessed at baseline and 6 months. Summary descriptive measures will be reported for all variables. Analysis of covariance will be used to compare study groups, while adjusting for baseline measurements and potential confounding variables. Subgroup analyses will be conducted based on sex/gender and region. Expected Outcomes: It is expected that older adults receiving the intervention will show greater improvements in health-related quality of life compared to usual home care services. These improvements will be achieved at no additional cost, from a societal perspective.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
December 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maureen Markle-Reid

Professor and Canada Research Chair, Co-Scientific Director of Aging, Community and Health Research Unit (ACHRU)

McMaster University

Eligibility Criteria

Inclusion Criteria

  • 65 years of age and older;
  • Three or more chronic conditions
  • Newly referred (following initiation of the study) for home care services and living in the community, including supportive housing, retirement homes, and lodging homes and excluding long-term care;
  • Able to speak English or have access to a translator;
  • Not planning to move away from the CCAC catchment area in the next 6 months;
  • Be mentally competent to provide informed consent, either independently or by a substitute decision maker.

Exclusion Criteria

  • Participants will be excluded if they are unable to read and understand English and do not have access to their own translator

Outcomes

Primary Outcomes

Physical Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)

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

The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.

Secondary Outcomes

  • Mental Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)(Baseline and end of study (6 months from baseline))
  • Team Climate Inventory-19 (TCI-19)(At 3 months and at 9 months after the start of the study)
  • Generalized Anxiety Disorder Screener (GAD-7) Scale(Baseline and end of study (6 months from baseline))
  • Health and Social Services Utilization Inventory (HSSUI)(Baseline and end of study (6 months from baseline))
  • Centre for Epidemiological Studies in Depression - Shortened version (CES-D-10)(Baseline and end of study (6 months from baseline))
  • Collaborative Practice Assessment Tool (CPAT)(At 3 months and at 9 months after the start of the study)
  • Self-efficacy for managing chronic disease scale(Baseline and end of study (6 months from baseline))

Study Sites (1)

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