Trial Outcomes & Findings for Occupational Therapy in Complex Patients: a Pilot Study (NCT NCT02677766)

Last Updated: 2019-09-09

Results Overview

The Canadian Occupational Performance Measure is a valid, evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time. The score is between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

T0 is the baseline at the patient ammission in the rehabilitation Ward; T2 is the follow-up at end of the intervention, 45 days ± 15 days from discharge

Results posted on

2019-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM occupational therapy: an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0.	Usual Care Usual care consists in rehabilitation treatment delivered by a multidisciplinary team Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
Overall Study STARTED	20	20
Overall Study COMPLETED	15	17
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=20 Participants Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM occupational therapy: an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0.	Usual Care n=20 Participants Usual care consists in rehabilitation treatment delivered by a multidisciplinary team Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=20 Participants	13 Participants n=20 Participants	20 Participants n=40 Participants
Age, Categorical >=65 years	13 Participants n=20 Participants	7 Participants n=20 Participants	20 Participants n=40 Participants
Age, Continuous	66.35 years STANDARD_DEVIATION 14.67 • n=20 Participants	62.75 years STANDARD_DEVIATION 10.99 • n=20 Participants	64 years STANDARD_DEVIATION 26.85 • n=40 Participants
Sex: Female, Male Female	8 Participants n=20 Participants	9 Participants n=20 Participants	17 Participants n=40 Participants
Sex: Female, Male Male	12 Participants n=20 Participants	11 Participants n=20 Participants	23 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Italy	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants

PRIMARY outcome

Timeframe: T0 is the baseline at the patient ammission in the rehabilitation Ward; T2 is the follow-up at end of the intervention, 45 days ± 15 days from discharge

Outcome measures

Outcome measures
Measure	Intervention n=15 Participants Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM occupational therapy: an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0.	Usual Care n=17 Participants Usual care consists in rehabilitation treatment delivered by a multidisciplinary team Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure	7.28 units on a scale Standard Deviation 1.67	4.77 units on a scale Standard Deviation 1.89

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Usual Care

Serious events: 0 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intervention n=20 participants at risk Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM occupational therapy: an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0.	Usual Care n=20 participants at risk Usual care consists in rehabilitation treatment delivered by a multidisciplinary team Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
Cardiac disorders referred to other wards for clinical reasons	0.00% 0/20 • to the end of the study, which means 45 days post hosèital discharge	5.0% 1/20 • Number of events 1 • to the end of the study, which means 45 days post hosèital discharge

Additional Information

Stefania Costi

University of Modena and Reggio Emilia

Phone: +390522522441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place