Functional Recovery and Caregiver Burden Following Surgery in the Elderly

Caregivers Clinical Trial

— FOCUS  

Official title:

Functional Recovery and Caregiver Burden Following Surgery in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382251
• Other study ID #: 2009390-01H
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: December 17, 2013
• Start date: July 2010
• Est. completion date: January 2012

Study information

• Verified date: December 2013
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Activities of Daily Living
• Ambulatory Surgical Procedures
• Caregivers

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Anesthesiologists' Society

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Bryson GL, Clavel NA, Moga R, Power B, Taljaard M, Nathan HJ. Patient function and caregiver burden after ambulatory surgery: a cohort study of patients older than 65. Can J Anaesth. 2013 Sep;60(9):864-73. doi: 10.1007/s12630-013-9982-y. Epub 2013 Jun 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Autonomy Measurement System (SMAF)	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	Yes
Secondary	Zarit Burden Interview (ZBI)	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	No
Secondary	Short Form 12	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	No
Secondary	Brief Pain Inventory (BPI) Functional Interference Score.	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	No