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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01382251
First Posted: June 27, 2011
Last Update Posted: January 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Anesthesiologists' Society
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  Purpose

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).

Condition
Activities of Daily Living Caregivers Ambulatory Surgical Procedures

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Functional Recovery and Caregiver Burden Following Surgery in the Elderly

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.


Enrollment: 123
Study Start Date: July 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patient
Patients undergoing ambulatory surgery
Caregiver
Spouse, family members, or friends identified as the patient's primary source of support in the community.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing ambulatory surgery and their primary caregivers
Criteria

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
  Contacts and Locations
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): NCT01382251


Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Anesthesiologists' Society
Investigators
Principal Investigator: Gregory L Bryson, FRCPC Department of Anesthesiology, The Ottawa Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01382251     History of Changes
Other Study ID Numbers: 2009390-01H
First Submitted: June 23, 2011
First Posted: June 27, 2011
Results First Submitted: July 3, 2013
Results First Posted: January 20, 2014
Last Update Posted: January 20, 2014
Last Verified: December 2013

Keywords provided by Ottawa Hospital Research Institute:
Activities of Daily Living
Caregivers
Ambulatory Surgical Procedures