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NCT Number: NCT01382251

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).

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Key information

Conditions

Activities of Daily Living Ambulatory Surgical Procedures Caregivers

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Anesthesiologists' Society

Registry information

Acronym: FOCUS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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