Trial Outcomes & Findings for Functional Recovery and Caregiver Burden Following Surgery in the Elderly (NCT NCT01382251)

NCT ID: NCT01382251

Last Updated: 2014-01-20

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 123 participants
• Primary outcome timeframe: Baseline, one week, and one month following surgery
• Results posted on: 2014-01-20

Participant Flow

Patients > 65 yrs scheduled to undergo elective ambulatory orthopedic or peritoneal surgeries were assessed for eligibility. Each patient must have a partner or adult descendant as primary caregiver. Patient-caregiver dyads were approached in the pre-admission unit. Screening began on 2010-07-01 and the final assessment was completed on 2012-01-04.

Participant milestones

Measure	Ambulatory Surgery Patients	Ambulatory Surgery Caregivers
Overall Study STARTED	123	123
Overall Study COMPLETED	102	102
Overall Study NOT COMPLETED	21	21

Reasons for withdrawal

Measure	Ambulatory Surgery Patients	Ambulatory Surgery Caregivers
Overall Study Surgeries cancelled or delayed	16	16
Overall Study Lost to Follow-up	4	4
Overall Study Contacted after study closed	1	1

Baseline Characteristics

Functional Recovery and Caregiver Burden Following Surgery in the Elderly

Baseline characteristics by cohort

Measure	Ambulatory Surgery Patients n=102 Participants Only patients with caregivers were recruited	Ambulatory Surgery Caregivers n=102 Participants Caregivers were recruited with the patients receiving surgery	Total n=204 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	30 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	102 Participants n=5 Participants	72 Participants n=7 Participants	174 Participants n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	47 Participants n=7 Participants	95 Participants n=5 Participants
Region of Enrollment Canada	102 participants n=5 Participants	102 participants n=7 Participants	204 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ambulatory Surgery Patients n=102 Participants	Ambulatory Surgery Caregivers n=102 Participants
Functional Autonomy Measurement System (SMAF) Baseline	4.0 units on a scale Standard Deviation 5.9	2.0 units on a scale Standard Deviation 2.9
Functional Autonomy Measurement System (SMAF) One Week Post-op	10.9 units on a scale Standard Deviation 7.6	NA units on a scale Standard Deviation NA Did not undergo surgery therefore no anticipated change in function
Functional Autonomy Measurement System (SMAF) One Month Post-op	6.7 units on a scale Standard Deviation 7.2	NA units on a scale Standard Deviation NA Did not undergo surgery therefore no anticipated change in function

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ambulatory Surgery Patients	Ambulatory Surgery Caregivers n=102 Participants
Zarit Burden Interview (ZBI) Baseline	—	9.3 units on a scale Standard Deviation 9.9
Zarit Burden Interview (ZBI) One Week Post-op	—	8.9 units on a scale Standard Deviation 9.8
Zarit Burden Interview (ZBI) One Month Post-Op	—	8.6 units on a scale Standard Deviation 10.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ambulatory Surgery Patients n=102 Participants	Ambulatory Surgery Caregivers n=102 Participants
Short Form 12 Mental Component Score (Baseline)	55.3 units on a scale Standard Deviation 7.5	55.9 units on a scale Standard Deviation 6.6
Short Form 12 Mental Component Score (One Week Post-op)	54.9 units on a scale Standard Deviation 8.8	54.4 units on a scale Standard Deviation 9.0
Short Form 12 Mental Component Score (One Month Post-Op)	56.2 units on a scale Standard Deviation 7.8	54.8 units on a scale Standard Deviation 8.0
Short Form 12 Physical Component Score (Baseline)	43.4 units on a scale Standard Deviation 12.7	50.5 units on a scale Standard Deviation 7.9
Short Form 12 Physical Component Score (One Week Post-op)	35.1 units on a scale Standard Deviation 10.3	51.2 units on a scale Standard Deviation 8.4
Short Form 12 Physical Component Score (One Month Post-op)	42.7 units on a scale Standard Deviation 11.4	51.3 units on a scale Standard Deviation 8.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ambulatory Surgery Patients n=102 Participants	Ambulatory Surgery Caregivers
Brief Pain Inventory (BPI) Functional Interference Score. Baseline	1.8 units on a scale Standard Deviation 2.4	—
Brief Pain Inventory (BPI) Functional Interference Score. One Week Post-op	2.1 units on a scale Standard Deviation 2.1	—
Brief Pain Inventory (BPI) Functional Interference Score. One Month Post-op	1.2 units on a scale Standard Deviation 1.7	—

Adverse Events

Ambulatory Surgery Patients

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ambulatory Surgery Patients n=102 participants at risk
Cardiac disorders Myocardial Infarction	0.98% 1/102 • Number of events 1 • 30 days following surgery Adverse event data not collected on caregivers as they did not undergo surgery.
Nervous system disorders Transient Ischemic Attack	0.98% 1/102 • Number of events 1 • 30 days following surgery Adverse event data not collected on caregivers as they did not undergo surgery.
Injury, poisoning and procedural complications Uncontrolled Pain	0.98% 1/102 • Number of events 1 • 30 days following surgery Adverse event data not collected on caregivers as they did not undergo surgery.
Injury, poisoning and procedural complications Small Bowel Perforation	0.98% 1/102 • Number of events 1 • 30 days following surgery Adverse event data not collected on caregivers as they did not undergo surgery.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gregory L Bryson

Department of Anesthesiology, The Ottawa Hospital

Phone: 613.761.4169

Email: glbryson@ottawahospital.on.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place