N/A
N=246
Functional Recovery and Caregiver Burden Following Surgery in the Elderly
Activities of Daily Living · Caregivers · Ambulatory Surgical Procedures
Bottom Line
View on ClinicalTrials.gov: NCT01382251 ↗Enrolled (actual)
246
Serious AEs
3.9%
Results posted
Jan 2014
Primary outcome: Primary: Functional Autonomy Measurement System (SMAF) — 4.0; 2.0; 10.9; NA units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Autonomy Measurement System (SMAF) |
4.0; 2.0; 10.9; NA; 6.7; NA | — |
| SECONDARY Zarit Burden Interview (ZBI) |
9.3; 8.9; 8.6 | — |
| SECONDARY Short Form 12 |
55.3; 55.9; 54.9; 54.4; 56.2; 54.8 | — |
| SECONDARY Brief Pain Inventory (BPI) Functional Interference Score. |
1.8; 2.1; 1.2 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01382251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.