NCT00134836

Brief Summary

It is recognized that a significant proportion of seniors over 75 years of age are at risk of functional decline, and thus of institutionalization and death. The investigators at McMaster University Medical Centre, are conducting is a randomized controlled trial of a preventive primary care outreach (PPCO) service provided to high risk seniors living in the community. The goal of this service is to identify unrecognized problems and individuals at increased risk and to link individuals to care. This preventive primary care service is provided by nurse case managers. The investigators have recruited patients through their family physicians who work in primary care networks. The investigators are screening all seniors aged 75 and over within these practices. The sample includes seniors aged 75 and over who are identified to be at risk according to the Sherbrooke Postal Questionnaire. Patients are randomly allocated to intervention and control groups. A research assistant, who is blind to group allocation, will collect data from seniors at baseline, six months, and at the end of one year. Outcome measures include health-related quality of life (quality adjusted life years \[QALYs\]), health and social service utilization and costs, mortality, institutionalization, functional status, and perceived health status. Primary Hypothesis: The intervention compared to usual care will result in higher health-related quality of life. Secondary Hypotheses: Compared to usual care, the PPCO intervention will result in:

  • the same or lower costs associated with service utilization;
  • less functional decline;
  • reduced mortality;
  • lower rates of institutionalization; and
  • better self-rated health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
719

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2004

Typical duration for phase_1

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

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

December 16, 2008

Status Verified

December 1, 2008

Enrollment Period

2.2 years

First QC Date

August 23, 2005

Last Update Submit

December 11, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life (quality adjusted life years [QALYs])

    baseline, 6 months, 12 months

Secondary Outcomes (5)

  • Health and social service utilization and costs

    baseline, 6 months, 12 months

  • mortality

    12 months

  • institutionalization

    12 months

  • functional status

    baseline, 6 months, 12 months

  • perceived health status

    baseline, 6 months, 12 months

Interventions

Nurse home visit at baseline, 6 months, 12 months, including comprehensive assessment using MDS HC, care planning, referral to appropriate services

Also known as: nurse home visit

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patient is 75 years of age and older
  • Patient is listed on the roster of a participating family physician practice
  • Patient resides in the Hamilton, Ontario, Canada area
  • Patient or proxy able to answer questions in English

You may not qualify if:

  • Principal residence is nursing home or long term care facility
  • Patient is identified by family physician as palliative
  • Patient currently receives home care services through the Community Care Access Centre
  • Patient is a 'snowbird' and out of town for more than four weeks in any year
  • Patient is scheduled for major elective surgery in the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (1)

  • Ploeg J, Brazil K, Hutchison B, Kaczorowski J, Dalby DM, Goldsmith CH, Furlong W. Effect of preventive primary care outreach on health related quality of life among older adults at risk of functional decline: randomised controlled trial. BMJ. 2010 Apr 16;340:c1480. doi: 10.1136/bmj.c1480.

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jenny Ploeg, RN, PhD

    School of Nursing, Faculty of Health Sciences, McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 25, 2005

Study Start

April 1, 2004

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

December 16, 2008

Record last verified: 2008-12

Locations