Functional Recovery and Caregiver Burden Following Surgery in the Elderly (FOCUS)

December 17, 2013 updated by: Ottawa Hospital Research Institute

The purpose of this study is to assess the functional recovery of older ambulatory surgical patients and the impact of the current model of care on the caregivers of these patients. This study will provide unique insight into the challenges patients and their families face following surgery.

The primary objective of this study is to:

  1. Assess the impact of ambulatory surgery on functional capacity as assessed by the Système de Mesure de l'Autonomie Fonctionnelle (SMAF) one week and one month following surgery in a population of surgical patients 65 years of age and older.

    Secondary objectives are to determine if:

  2. Changes in the patient's functional capacity result in increased burden of care as assessed by the Zarit Burden Interview (ZBI) in the patient's primary caregiver.
  3. Changes in functional capacity are correlated with decrements in quality of life as assessed by the Short Form 12 (SF12).
  4. Changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the Brief Pain Inventory (BPI).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

123

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing ambulatory surgery and their primary caregivers

Description

Inclusion Criteria:

Patients

  • aged 65 years and older
  • elective surgery with a planned discharge to the community on the day of the surgical procedure.
  • Eligible surgical procedures include: inguinal herniorrhaphy, ventral herniorrhaphy, laparoscopic cholecystectomy,laparoscopic salpingoophorectomy, urethropexy, cystocoele/rectocoele repair, vaginal hysterectomy, arthroscopic debridement (knee, hip, shoulder), arthroscopic repair (knee, hip, shoulder), removal of hardware from lower extremity, foot surgery, and lumbar discectomy.

Caregiver

- spouses, family members, or friends identified as the patient's primary source of support in the community.

Exclusion Criteria:

Patients

  • Reside in a nursing home providing professional support services;
  • Are unable to complete the study instruments due to cognitive (MMSE <24) or physical impairment;
  • Are unable to speak English or French

Caregiver

  • Professional caregivers (nurse, personal care assistant, etc) hired to care for the patient;
  • Unable to complete the study instruments due to physical impairment;
  • Unable to Speak English or French

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patient
Patients undergoing ambulatory surgery
Caregiver
Spouse, family members, or friends identified as the patient's primary source of support in the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Autonomy Measurement System (SMAF)
Time Frame: Baseline, one week, and one month following surgery
29-item scale, each item graded on a four-point scale. 0= independent, 1= needs supervision,2 = needs help, 3 = dependent. Total score ranges from 0 to 87 with higher scores indicating increased disability
Baseline, one week, and one month following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Zarit Burden Interview (ZBI)
Time Frame: Baseline, one week, and one month following surgery
A 22-item questionnaire in which subjects rate how often they experience negative feelings associated with caregiving. Each item rated on a 5 point scale anchored at 0 for "never" and 4 for "nearly always." Scores range from 0-88 with higher scores indicating increased burden of care.
Baseline, one week, and one month following surgery
Short Form 12
Time Frame: Baseline, one week, and one month following surgery
A validated measure of health related quality of life comprised of 12 questions regarding participant experience over the preceding week. Generate Physical And Mental Component scores ranging from 0-100 with higher scores indicating better quality of life.
Baseline, one week, and one month following surgery
Brief Pain Inventory (BPI) Functional Interference Score.
Time Frame: Baseline, one week, and one month following surgery
Comprised of seven questions in which the subject is asked to describe the extent to which pain interferes with activity. Scores are anchored at 0 for "does not interfere" and 10 for "completely interferes." The seven resulting scores are averaged and reported as a single value (0 - 10) with higher scores indicating greater interference with function.
Baseline, one week, and one month following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Canadian Anesthesiologists' Society

Investigators

  • Principal Investigator: Gregory L Bryson, FRCPC, Department of Anesthesiology, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009390-01H

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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