Primary Healthcare for Community Living Old Elderly

March 14, 2016 updated by: Marshal Godwin, Memorial University of Newfoundland

The ElderCare Project: Primary Healthcare for Community Living Old Elderly

Hypothesis: It is hypothesized that older adults who receive the ElderCare intervention will, when compared with a control group of older adults show a significant improvement in quality of life,a significant decrease in symptomatology, significantly higher satisfaction with their care, and less utilization of health care resources.

The Eldercare project involves a detailed assessment by a nurse done in the patients home, followed by the development and delivery of a Eldercare Plan using a Goal Attainment Scaling approach.

Outcomes include quality of life, symptomatology, satisfaction, and health care utilization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives: The main objective of this study is to improve the care of the old elderly. This will be done by implementing and evaluating a year long program which is intended to optimize quality of life, symptom management and utilization of both health care and community services for the old elderly.

Hypothesis: It is hypothesized that older adults who receive the ElderCare intervention will, when compared with a control group of older adults: a) show a significant improvement in quality of life - as measured by the SF-36, b) show a significant decrease in symptomatology - as measured by the Comorbidity Symptom Scale, c) show significantly higher satisfaction - as measured by the Patient Satisfaction Questionnaire d) have increased utilization of community-based services, e) have fewer emergency room visits, f) have fewer hospitalizations, and g) fewer visits to the family doctor

Research Plan: The ElderCare program is a nurse-based program of home-delivered care that will be linked directly with the primary care practitioner or primary care team of each older adult in the study. The nurse will be part of the primary health care team for a number of different family physicians practices. The nurse will serve as a link or interface between the family physicians practice (or other primary health care professional or team) and the community services. The nurse will i) evaluate the clinical and personal needs of the patient, ii) develop a management plan based on that review (the review includes chart review, patient assessment and contacting community agencies that have been involved with the patients care). , iii)review the plan with the family physician and the patient/family; iv) implement the plan v) provide patient education; and vi) monitor the patient regularly in his/her home over the course of a year. Evaluation will involve comparing a group of old elderly who receive the ElderCare program (intervention) with a control group. Groups will be evaluated using a variety of assessments which will be done at baseline, 6 months and 12 months.

The steps that will be taken in carrying out the research are outlined as follows:

  1. Physician Recruitment
  2. Patient Recruitment
  3. Baseline Data Collection
  4. Randomization - Physicians will be cluster randomized to decrease contamination
  5. ElderCare Program delivered to intervention group old elderly
  6. Usual care for control group old elderly
  7. Outcomes measured at 6 and twelve months - outcomes include quality of life, change in symptomatology, patient satisfaction, use of community services, visits to family doctor, hospitalizations, emergency room visits
  8. Data Analysis, Interpretation, Reporting and Analysis

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Primary Healthcare Research Unit, Memorial University of Newfoundland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of a family practice who are 80 years or older, who are independently living and do not have a diagnosis of dementia.

Exclusion Criteria:

  • MMSE score 25 or less

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual Care
Experimental: Intervention
A research nurse will meet with participants, complete a detailed nursing assessment and develop of a care plan to help connect participants with resources to allow them to stay in their homes longer.
Nursing assessment and development of an appropriate care plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: Prospective
Prospective
Symptomology
Time Frame: Prospectiv e
Prospectiv e
Satisfaction
Time Frame: Prospective
Prospective
Health care service utilization
Time Frame: Prospective
Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marshall Godwin, MD, Memorial University of Newfoundland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 26, 2007

First Posted (Estimate)

March 27, 2007

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 200603MOP-158331-SDA-CJAA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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