RehabilitationNCT03668938
Occupational Therapy Intervention in Patients With Complex Needs to Improve Social Reintegration
A study testing Occupational Therapy in people with Rehabilitation and Occupational Therapy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
A previous study that involved the intervention of the occupational therapist (OT) on complex patients both in hospital and at home showed the effectiveness of OT during hospitalization. The effectiveness was not demonstrated in the post-discharge phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rehabilitation, Occupational Therapy
- What is being tested?
- Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 8 Oct 2018to 23 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complex impatient
- Admitted to AUSL-IRCCS/UO MFR
Who cannot join
- Language barriers
- Severe cognitive impairment
- Psychiatric disorders
- Domiciled in a protected facility at the time of admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Occupational Therapy in the Rehabilitation of Complex Patients: Randomized Controlled Trial
A previous study that involved the intervention of the occupational therapist (OT) on complex patients both in hospital and at home showed the effectiveness of OT during hospitalization. The effectiveness was not demonstrated in the post-discharge phase. Now, the investigators presented a RCT to compare the levels of social reintegration between the intervention group and control group. The hypothesis is that the intervention group obtains a higher and clinically relevant level of social reintegration compared to the group treated with the usual care.
Read the detailed description
In the previous study, the intervention group achieved higher gains in the return to normal life than in the control group, but this difference did not reach statistical significance. Because of this, a new study was implemented with the correct sample size, defined through the previous study. In addition, the post-discharge phase the COPM was administered to define new objectives relating mainly to productivity and leisure time areas. Finally, the investigators have indentified some territorial services with the aim to create tailored paths/interventions for patients to promote social reintegration.
- Conditions
- Rehabilitation, Occupational Therapy
- Being tested
- Occupational Therapy, usual care
- Keywords
- Occupational Therapy, Complex Patient, Randomized Control Trial, Social Reintegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyOther
The intervention in the hospitalization phase is mainly aimed at achieving the objectives related to the self-care area and, secondly, to the objectives in the areas of productivity and leisure time, identified in T0 and to the environmental assessment of the places of life of the patient; more an intervention in the patient's post-discharge home, mainly aimed at achieving the objectives related to social reintegration, the area of productivity and leisure time and, secondly, to possible objectives in the areas of self-care identified in T1.
usual careOther
Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | The occupational therapy intervention provides a treatment aimed at improving autonomy in the activities chosen by the patient Receives: Other: Occupational Therapy; Other: usual care |
| 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 in Reintegration to Normal Living Index
Compare the change in the level of reintegration to normal life between the two arms. The score range is from 1 to 100. Higher values represent a better outcome.
Measured: Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Secondary outcomes (5)
Canadian Occupational Performance Measure
Compare the results obtained in the two groups in the performance and satisfaction perceived by the patient in carrying out the occupational activities identified as priorities. The score range is from 1 to 10. Higher values represent a better outcome.
Measured: Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Modified Barthel Index
Compare the results obtained in the two groups in autonomy in the activities of daily life. The score range is from 1 to 100. Higher values represent a better outcome.
Measured: Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Instrumental Activity of Daily Living
Compare the results obtained in the two groups in autonomy in instrumental activities. The score range is from 1 to 8. Lower values represent a better outcome.
Measured: Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Hospital Anxiety and Depression Scale
Compare the results obtained in the two groups in anxiety and depression.The scale has 2 subscales that evaluates anxiety and depression, respectively. For both subscales the score range is from 0 to 21. Higher values represent a better outcome.
Measured: Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Short Form 12
Compare the results obtained in the two groups in the quality of life. The scale has 2 subscales. The Physical Component Summary has a score range from 11 to 70. The other subscale evaluates the Mental Component Summary with a score range from 7 to 72. Higher values represent a better outcome.
Measured: Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 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 posted13 Sep 2018
- Study start8 Oct 2018
- Primary completion23 Sep 2020
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stefania Fugazzaro, Principal investigator, Local Health Autority of Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668938
- Sponsor's protocol ID
- COMPLE-TO_2018
- Status last verified
- Jul 2022
- First submitted
- 14 Aug 2018
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Costi S, Pellegrini M, Braglia L, Cavuto S, Fugazzaro S. Occupational therapy improves social participation of complex patients discharged from hospital: results of a powered randomized controlled trial. Disabil Rehabil. 2024 Jun;46(11):2223-2233. doi: 10.1080/09638288.2023.2218653. Epub 2023 Jun 1.
PubMed 37259592
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Occupational Therapy in the Rehabilitation of Complex Patients: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03668938
- Acronym / sponsor ID
- COMPLE-TO_2018
- Conditions
- Rehabilitation, Occupational Therapy
- Keywords
- Occupational Therapy, Complex Patient, Randomized Control Trial, Social Reintegration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A previous study that involved the intervention of the occupational therapist (OT) on complex patients both in hospital and at home showed the effectiveness of OT during hospitalization. The effectiveness was not demonstrated in the post-discharge phase. Now, the investigators presented a RCT to compare the levels of social reintegration between the intervention group and control group. The hypothesis is that the intervention group obtains a higher and clinically relevant level of social reintegration compared to the group treated with the usual care.
Detailed description
In the previous study, the intervention group achieved higher gains in the return to normal life than in the control group, but this difference did not reach statistical significance. Because of this, a new study was implemented with the correct sample size, defined through the previous study. In addition, the post-discharge phase the COPM was administered to define new objectives relating mainly to productivity and leisure time areas. Finally, the investigators have indentified some territorial services with the aim to create tailored paths/interventions for patients to promote social reintegration.
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 Therapy, Other: usual careThe occupational therapy intervention provides a treatment aimed at improving autonomy in the activities chosen by the patient |
| usual care | Active comparator | Other: usual careUsual care consists in rehabilitation treatment delivered by a multidisciplinary team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complex impatient
- Admitted to AUSL-IRCCS/UO MFR
Key exclusion criteria (4 listed)
- Language barriers
- Severe cognitive impairment
- Psychiatric disorders
- Domiciled in a protected facility at the time of admission
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 TherapyThe intervention in the hospitalization phase is mainly aimed at achieving the objectives related to the self-care area and, secondly, to the objectives in the areas of productivity and leisure time, identified in T0 and to the environmental assessment of the places of life of the patient; more an intervention in the patient's post-discharge home, mainly aimed at achieving the objectives related to social reintegration, the area of productivity and leisure time and, secondly, to possible objectives in the areas of self-care identified in T1. | Other | intervention |
| usual careUsual care consists in rehabilitation treatment delivered by a multidisciplinary team | Other | intervention, usual care |
Primary outcome
Change in Reintegration to Normal Living Index
Time frame: Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Compare the change in the level of reintegration to normal life between the two arms. The score range is from 1 to 100. Higher values represent a better outcome.
5 secondary outcomes
Canadian Occupational Performance Measure
Time frame: Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Modified Barthel Index
Time frame: Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Instrumental Activity of Daily Living
Time frame: Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Hospital Anxiety and Depression Scale
Time frame: Time 0 is the baseline at the patient ammission in the rehabilitation ward; Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Short Form 12
Time frame: Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 days ± 15 days from discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Derived from this study: PubMed 37259592Costi S, Pellegrini M, Braglia L, Cavuto S, Fugazzaro S. Occupational therapy improves social participation of complex patients discharged from hospital: results of a powered randomized controlled trial. Disabil Rehabil. 2024 Jun;46(11):2223-2233. doi: 10.1080/09638288.2023.2218653. Epub 2023 Jun 1.
- Individual participant dataSharing planned: No
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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.
Stefania Fugazzaro principal investigator
Local Health Autority of Reggio Emilia
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 Rehabilitation and Occupational Therapy, run by Azienda USL Reggio Emilia - IRCCS 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 2 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 24 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in Reintegration to Normal Living Index (time frame: Time 1 is on average 45 days from Time 0 (discharge from the rehabilitation ward); Time 2 is at 90 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 NCT03668938, 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 24 Jun 2025.