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临床试验/NCT02209285
NCT02209285已完成不适用

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

McMaster University2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Physical Component Summary Score of the Short-Form 12 Health Survey, Version 2 (SF-12v2)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maureen Markle-Reid

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

McMaster University

研究点 (2)

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