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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Ottawa Hospital Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Canadian Anesthesiologists' Society
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01382251
First received: June 23, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted

June 23, 2011
June 23, 2011
July 2010
Not Provided
Système de Mesure de l'Autonomie Fonctionnelle (SMAF) [ Time Frame: One week and one month following surgery ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • Zarit Burden Interview (ZBI) [ Time Frame: One week and one month following surgery ] [ Designated as safety issue: No ]
  • Short Form 12 [ Time Frame: One week and one month following surgery ] [ Designated as safety issue: No ]
  • Brief Pain Inventory (BPI) [ Time Frame: One week and one month following surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Functional Recovery and Caregiver Burden Following Surgery in the Elderly
Functional Recovery and Caregiver Burden Following Surgery in the Elderly

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).
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients undergoing ambulatory surgery and their primary caregivers

  • Activities of Daily Living
  • Caregivers
  • Ambulatory Surgical Procedures
Not Provided
  • Patient
    Patients undergoing ambulatory surgery
  • Caregiver
    Spouse, family members, or friends identified as the patient's primary source of support in the community.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
Not Provided

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
Both
65 Years and older
No
Contact: Gregory L Bryson, FRCPC 613.598.5555 ext 14169 glbryson@ottawahospital.on.ca
Contact: Sharon Finlay, RN 613.598.5555 ext 15495 sfinlay@ottawahospital.on.ca
Canada
 
NCT01382251
2009390-01H
No
Nancy Camack, Director Clinical and Translational Research Administration, Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Canadian Anesthesiologists' Society
Principal Investigator: Gregory L Bryson, FRCPC Department of Anesthesiology, The Ottawa Hospital
Ottawa Hospital Research Institute
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP