Self-Management Program for Older Adults With Multimorbidity

Multimorbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209285
• Other study ID #: STRCT- 06669
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2020
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multimorbidity

Intervention

Behavioral:
• Self-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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)	The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.	Baseline and end of study (6 months from baseline)
Secondary	Generalized Anxiety Disorder Screener (GAD-7) Scale	The GAD-7 will be administered to older adult participants at baseline and 6 months to assess anxiety.	Baseline and end of study (6 months from baseline)
Secondary	Health and Social Services Utilization Inventory (HSSUI)	The HSSUI will be administered to older adult participants at baseline and 6 months to assess healthcare utilization costs.	Baseline and end of study (6 months from baseline)
Secondary	Centre for Epidemiological Studies in Depression - Shortened version (CES-D-10)	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.	Baseline and end of study (6 months from baseline)
Secondary	Collaborative Practice Assessment Tool (CPAT)	The 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.	At 3 months and at 9 months after the start of the study
Secondary	Mental Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)	The Short-Form 12 Health Survey will be administered to older adult participants to measure health-related quality of life.	Baseline and end of study (6 months from baseline)
Secondary	Self-efficacy for managing chronic disease scale	The self-efficacy for managing chronic disease scale will be administered to older adult participants to assess their level of self-efficacy	Baseline and end of study (6 months from baseline)
Secondary	Team Climate Inventory-19 (TCI-19)	The 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.	At 3 months and at 9 months after the start of the study