Functional Recovery and Caregiver Burden Following Surgery in the Elderly (FOCUS)
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|ClinicalTrials.gov Identifier: NCT01382251|
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : January 20, 2014
Last Update Posted : January 20, 2014
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:
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:
- 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.
- Changes in functional capacity are correlated with decrements in quality of life as assessed by the Short Form 12 (SF12).
- Changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the Brief Pain Inventory (BPI).
|Condition or disease|
|Activities of Daily Living Caregivers Ambulatory Surgical Procedures|
|Study Type :||Observational|
|Actual Enrollment :||123 participants|
|Official Title:||Functional Recovery and Caregiver Burden Following Surgery in the Elderly|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Patients undergoing ambulatory surgery
Spouse, family members, or friends identified as the patient's primary source of support in the community.
- 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
- 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.
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
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Principal Investigator:||Gregory L Bryson, FRCPC||Department of Anesthesiology, The Ottawa Hospital|