Functional Recovery and Caregiver Burden Following Surgery in the Elderly

NCT01382251 | Completed Results

• 1 other identifier: 2009390-01H
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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. 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.
2. 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. 3.Changes in functional capacity are correlated with decrements in quality of life as assessed by the Short Form 12 (SF12).
4. 4.Changes in functional capacity are correlated with inadequate postoperative analgesia as assessed by the Brief Pain Inventory (BPI).

Conditions

Activities of Daily Living; Caregivers; Ambulatory Surgical Procedures

Keywords

Activities of Daily Living; Caregivers; Ambulatory Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Zarit Burden Interview (ZBI)

  Baseline, one week, and one month following surgery

• Short Form 12

  Baseline, one week, and one month following surgery

• Brief Pain Inventory (BPI) Functional Interference Score.

  Baseline, one week, and one month following surgery

Study Arms (2)

Patient

Patients undergoing ambulatory surgery

Caregiver

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing ambulatory surgery and their primary caregivers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Anesthesiologists' Society: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (2)

• 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.

  PMID: 23771742 RESULT

• Bryson GL, Mercer C, Varpio L. Patient and caregiver experience following ambulatory surgery: qualitative analysis in a cohort of patients 65 yr and older. Can J Anaesth. 2014 Nov;61(11):986-94. doi: 10.1007/s12630-014-0229-3. Epub 2014 Sep 9.

  PMID: 25200593 DERIVED

Limitations and Caveats

Single center, relatively infrequent assessment, assessment of caregiver burden limited to primary caregiver, majority of caregivers were not employed outside the home.

Results Point of Contact

• Title: Dr. Gregory L Bryson
• Organization: Department of Anesthesiology, The Ottawa Hospital

glbryson@ottawahospital.on.ca

613.761.4169

Study Officials

• Gregory L Bryson, FRCPC

  Department of Anesthesiology, The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 20, 2014
• Results First Posted: January 20, 2014

Record last verified: 2013-12

Locations

CA (1)