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Primary Healthcare for Community Living Old Elderly

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ClinicalTrials.gov Identifier: NCT00452465
Recruitment Status : Completed
First Posted : March 27, 2007
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Marshal Godwin, Memorial University of Newfoundland

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Care of the Elderly Behavioral: ElderCare Plan Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The ElderCare Project: Primary Healthcare for Community Living Old Elderly
Study Start Date : February 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Arm Intervention/treatment
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.
Behavioral: ElderCare Plan
Nursing assessment and development of an appropriate care plan.

No Intervention: Control
Usual Care



Primary Outcome Measures :
  1. Quality of Life [ Time Frame: Prospective ]
  2. Symptomology [ Time Frame: Prospectiv e ]
  3. Satisfaction [ Time Frame: Prospective ]
  4. Health care service utilization [ Time Frame: Prospective ]


Information from the National Library of Medicine

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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452465


Locations
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Canada, Newfoundland and Labrador
Primary Healthcare Research Unit, Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Sponsors and Collaborators
Memorial University of Newfoundland
Investigators
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Principal Investigator: Marshall Godwin, MD Memorial University of Newfoundland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marshal Godwin, Professor, Faculty of Medicine, Memorial University of Newfoundland
ClinicalTrials.gov Identifier: NCT00452465     History of Changes
Other Study ID Numbers: 200603MOP-158331-SDA-CJAA
First Posted: March 27, 2007    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Marshal Godwin, Memorial University of Newfoundland:
Elderly
Nursing care plan
Quality of Life