NCT02209285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2014

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

July 7, 2014

Last Update Submit

January 28, 2020

Conditions

Multimorbidity

Keywords

Older adultsHome and community careEffectivenessCost analysisPragmatic trialSelf-management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

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

    Baseline and end of study (6 months from baseline)

  • +2 more secondary outcomes

Study Arms (2)

Control group

NO INTERVENTION

The control group will receive usual care, which is provided by the community care access centre (CCAC). Usual care may include in-home visits by regulated health care providers, personal support workers, and care coordination through the community care access centre. Case conferences may occur on an as-needed basis.

Self-Management Program for Older Adults with Multimorbidity

ACTIVE COMPARATOR

Individuals in the intervention group will receive a six-month self-management 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.

Behavioral: Self-Management Program for Older Adults with Multimorbidity

Interventions

Self-Management Program for Older Adults with MultimorbidityBEHAVIORAL

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.

Self-Management Program for Older Adults with Multimorbidity

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (1)

  • Markle-Reid M, Ploeg J, Valaitis R, Duggleby W, Fisher K, Fraser K, Ganann R, Griffith LE, Gruneir A, McAiney C, Williams A. Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. J Comorb. 2018 Jul 31;8(1):2235042X18789508. doi: 10.1177/2235042X18789508. eCollection 2018.

    PMID: 30191144DERIVED

MeSH Terms

Interventions

Self-ManagementAgingMultimorbidity

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and ServicesGrowth and DevelopmentPhysiological PhenomenaComorbidityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Maureen Markle-Reid, RN, PhD

    McMaster University, School of Nursing

    PRINCIPAL INVESTIGATOR

  • Jenny Ploeg, RN, PhD

    McMaster University, School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Canada Research Chair, Co-Scientific Director of Aging, Community and Health Research Unit (ACHRU)

Study Record Dates

First Submitted

July 7, 2014

First Posted

August 5, 2014

Study Start

January 1, 2016

Primary Completion

April 1, 2017

Study Completion

December 1, 2017

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)