Clinical trial NCT00452465: Primary Healthcare for Community Living Old Elderly
Official title: The ElderCare Project: Primary Healthcare for Community Living Old Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Care of the Elderly
Keywords: Elderly
Nursing care plan
Quality of Life
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
First posted: 2007-03-27
Enrollment: 236
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility 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

Primary outcomes:
measure: Quality of Life
timeFrame: Prospective
measure: Symptomology
timeFrame: Prospectiv e
measure: Satisfaction
timeFrame: Prospective
measure: Health care service utilization
timeFrame: Prospective
Secondary outcomes:
Other outcomes:
Locations:
city: St. John's
country: Canada
facility: Primary Healthcare Research Unit, Memorial University of Newfoundland
state: Newfoundland and Labrador
Study officials:
affiliation: Memorial University of Newfoundland
name: Marshall Godwin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.