Complex Patients in Rehabilitation PhaseTO_EFFI15_14NCT02677766
Occupational Therapy in Complex Patients: a Pilot Study
A study testing occupational therapy in people with Complex Patients in Rehabilitation Phase, run by Stefania Costi at 1 site in Italy.
Trial summary
To date, there are no studies that demonstrate that the intervention of Occupational Therapy (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical and functional outcome for the patient. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Complex Patients in Rehabilitation Phase
- What is being tested?
- occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2016to 20 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- complex inpatient
Who cannot join
- primary psychiatric disorders,
- language barriers,
- severe cognitive impairment
- communication disability
Trial locations and contacts
1 site in 1 country.
About this study
To date, there are no studies that demonstrate that the intervention of Occupational Therapy (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical and functional outcome for the patient. For this reason, the investigators propose one randomized controlled trial that will compare the group receiving the intervention of OT and the control group, to quantify the level of performance and satisfaction in the activities of interest of the patient, identified through the COPM. The hypothesis is that the benefit may be higher, as clinically relevant, in the group of complex patients treated with the proposed intervention of OT compared to those receiving the usual rehabilitation therapy.
Read the detailed description
The investigators already implemented an observational pilot study, aimed at defining the characteristics and needs of the population in question and the OT intervention characteristics. These information will now be used to implement this randomized controlled trial, designed to demonstrate the effectiveness of the OT intervention on the basis of clinically relevant outcome measures.
This study will be set with exploratory purposes, with appropriate high number, which will allow the investigators to quantify the difference between the two groups in terms of performance scores derived from the COPM (COPM_p). From the results of this part it will then depend on the planning for the subsequent study with the correct sample size.
- Conditions
- Complex Patients in Rehabilitation Phase
- Being tested
- occupational therapy, Usual care
- Keywords
- Occupational Therapy, Complex patients, Randomized controlled trial, Occupational performance problem, Rehabilitation Complexity Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
occupational therapyOther
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 careOther
Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM Receives: Other: occupational therapy |
| usual care | Active comparator | Usual care consists in rehabilitation treatment delivered by a multidisciplinary team Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2017
- Study completion20 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complex Patients in Rehabilitation PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stefania Costi
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Responsible party
- Sponsor-investigator, Stefania Costi, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677766
- Sponsor's protocol ID
- TO_EFFI15_14
- Acronym
- TO_EFFI15_14
- Status last verified
- Sep 2019
- First submitted
- 29 Jan 2016
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Pellegrini M, Formisano D, Bucciarelli V, Schiavi M, Fugazzaro S, Costi S. Occupational Therapy in Complex Patients: A Pilot Randomized Controlled Trial. Occup Ther Int. 2018 Sep 3;2018:3081094. doi: 10.1155/2018/3081094. eCollection 2018.
PubMed 30250407
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy in Complex Patients: a Pilot Study
- ClinicalTrials.gov ID
- NCT02677766
- Acronym / sponsor ID
- TO_EFFI15_14 / TO_EFFI15_14
- Conditions
- Complex Patients in Rehabilitation Phase
- Keywords
- Occupational Therapy, Complex patients, Randomized controlled trial, Occupational performance problem, Rehabilitation Complexity Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stefania CostiUniversity, hospital or other
- Collaborators
- Azienda USL Reggio Emilia - IRCCS
- Study start
- Feb 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- 20 Oct 2017 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To date, there are no studies that demonstrate that the intervention of Occupational Therapy (OT) in patients considered to be complex, regardless of diagnosis, could improve clinical and functional outcome for the patient. For this reason, the investigators propose one randomized controlled trial that will compare the group receiving the intervention of OT and the control group, to quantify the level of performance and satisfaction in the activities of interest of the patient, identified through the COPM. The hypothesis is that the benefit may be higher, as clinically relevant, in the group of complex patients treated with the proposed intervention of OT compared to those receiving the usual rehabilitation therapy.
Detailed description
The investigators already implemented an observational pilot study, aimed at defining the characteristics and needs of the population in question and the OT intervention characteristics. These information will now be used to implement this randomized controlled trial, designed to demonstrate the effectiveness of the OT intervention on the basis of clinically relevant outcome measures.
This study will be set with exploratory purposes, with appropriate high number, which will allow the investigators to quantify the difference between the two groups in terms of performance scores derived from the COPM (COPM_p). From the results of this part it will then depend on the planning for the subsequent study with the correct sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: occupational therapyIntervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM |
| usual care | Active comparator | Other: Usual careUsual care consists in rehabilitation treatment delivered by a multidisciplinary team |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- complex inpatient
Key exclusion criteria (4 listed)
- primary psychiatric disorders,
- language barriers,
- severe cognitive impairment
- communication disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| occupational therapyan 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. | Other | Intervention |
| Usual careUsual care consists in rehabilitation treatment delivered by a multidisciplinary team | Other | usual care |
Primary outcome
Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure
Time frame: 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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30250407Pellegrini M, Formisano D, Bucciarelli V, Schiavi M, Fugazzaro S, Costi S. Occupational Therapy in Complex Patients: A Pilot Randomized Controlled Trial. Occup Ther Int. 2018 Sep 3;2018:3081094. doi: 10.1155/2018/3081094. eCollection 2018.
- Individual participant dataSharing planned: Yes
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Rehabilitation, Frailty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing occupational therapy in people with Complex Patients in Rehabilitation Phase, run by Stefania Costi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to Follow-up of the Performance Score at the Canadian Occupational Performance Measure (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02677766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.