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Self-Management Program for Older Adults With Multimorbidity

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02209285
Enrollment
59
Registered
2014-08-05
Start date
2016-01-31
Completion date
2017-12-31
Last updated
2020-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multimorbidity

Keywords

Older adults, Home and community care, Effectiveness, Cost analysis, Pragmatic trial, Self-management

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.

Interventions

BEHAVIORALSelf-Management Program for Older Adults with Multimorbidity

Individuals in the intervention group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

MeasureTime frameDescription
Health and Social Services Utilization Inventory (HSSUI)Baseline and end of study (6 months from baseline)The HSSUI will be administered to older adult participants at baseline and 6 months to assess healthcare utilization costs.
Centre for Epidemiological Studies in Depression - Shortened version (CES-D-10)Baseline and end of study (6 months from baseline)The CES-D-10 will be administered to older adult participants at baseline and 6 months to assess depressive symptoms It is estimated that approximately 70% of the study participants will have a family caregiver.
Collaborative Practice Assessment Tool (CPAT)At 3 months and at 9 months after the start of the studyThe CPAT will be administered to participating home care providers at 3 months and 9 months after initiation of the intervention to assess changes in collaborative practice.
Generalized Anxiety Disorder Screener (GAD-7) ScaleBaseline and end of study (6 months from baseline)The GAD-7 will be administered to older adult participants at baseline and 6 months to assess anxiety.
Self-efficacy for managing chronic disease scaleBaseline and end of study (6 months from baseline)The self-efficacy for managing chronic disease scale will be administered to older adult participants to assess their level of self-efficacy
Team Climate Inventory-19 (TCI-19)At 3 months and at 9 months after the start of the studyThe TCI-19 will be administered to participating home care providers at 3 months and 9 months after initiation of the intervention to assess the level of team functioning.
Mental Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026