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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

Tracking Information
First Submitted Date  ICMJE March 26, 2007
First Posted Date  ICMJE March 27, 2007
Last Update Posted Date March 16, 2016
Study Start Date  ICMJE February 2007
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2007)
  • Quality of Life [ Time Frame: Prospective ]
  • Symptomology [ Time Frame: Prospectiv e ]
  • Satisfaction [ Time Frame: Prospective ]
  • Health care service utilization [ Time Frame: Prospective ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2007)
  • Quality of Life
  • Symptomology
  • Satisfaction
  • Health care service utilization
Change History Complete list of historical versions of study NCT00452465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Primary Healthcare for Community Living Old Elderly
Official Title  ICMJE The ElderCare Project: Primary Healthcare for Community Living Old Elderly
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Care of the Elderly
Intervention  ICMJE Behavioral: ElderCare Plan
Nursing assessment and development of an appropriate care plan.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: ElderCare Plan
  • No Intervention: Control
    Usual Care
Publications * Godwin M, Pike A, McCrate F, Parsons K, Parsons W, Pitcher H, Buehler S, Gadag V, Miller R, Sclater A. The healthy aged: Descriptive analysis by sex of cognitively functioning elderly patients 80 years and older living independently in the community. Can Fam Physician. 2015 Mar;61(3):e142-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 19, 2014)
236
Original Enrollment  ICMJE
 (submitted: March 26, 2007)
320
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 80 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00452465
Other Study ID Numbers  ICMJE 200603MOP-158331-SDA-CJAA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marshal Godwin, Memorial University of Newfoundland
Study Sponsor  ICMJE Memorial University of Newfoundland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marshall Godwin, MD Memorial University of Newfoundland
PRS Account Memorial University of Newfoundland
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP