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Care of the ElderlyNCT00452465

Primary Healthcare for Community Living Old Elderly

A study testing ElderCare Plan in people with Care of the Elderly, run by Memorial University of Newfoundland at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 80 years and older
Conditions the study is for
Care of the Elderly
What is being tested?
ElderCare Plan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
1 siteCanada
Study dates
Feb 2007to Oct 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

  • MMSE score 25 or less

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Primary Healthcare Research Unit, Memorial University of Newfoundland

    St. John's, Newfoundland and Labrador, A1B 3V6

Other trials in Canada

About this study

Official title: 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.

Read the 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
Being tested
ElderCare Plan
Keywords
Elderly, Nursing care plan, Quality of Life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElderCare PlanBehavioural

    Nursing assessment and development of an appropriate care plan.

Study groups in NCT00452465
Study groupRoleWhat they receive
InterventionExperimentalA 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.
Receives: Behavioral: ElderCare Plan
ControlNo interventionUsual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life

    Measured: Prospective

  2. Symptomology

    Measured: Prospectiv e

  3. Satisfaction

    Measured: Prospective

  4. Health care service utilization

    Measured: Prospective

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00452465
Sponsor's protocol ID
200603MOP-158331-SDA-CJAA
Status last verified
Mar 2016
First submitted
26 Mar 2007
Last updated
16 Mar 2016
Results posted
No
Data monitoring committee
No

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.

    PubMed 25932481

Questions about this trial

What is this clinical trial studying?

A study testing ElderCare Plan in people with Care of the Elderly, run by Memorial University of Newfoundland at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (time frame: Prospective). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00452465, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.

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