- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00452465
Primary Healthcare for Community Living Old Elderly
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
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:
- Physician Recruitment
- Patient Recruitment
- Baseline Data Collection
- Randomization - Physicians will be cluster randomized to decrease contamination
- ElderCare Program delivered to intervention group old elderly
- Usual care for control group old elderly
- 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
- Data Analysis, Interpretation, Reporting and Analysis
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1B 3V6
- Primary Healthcare Research Unit, Memorial University of Newfoundland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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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.
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Nursing assessment and development of an appropriate care plan.
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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
Investigators
- Principal Investigator: Marshall Godwin, MD, Memorial University of Newfoundland
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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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