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Completed

NCT Number: NCT03668938

Occupational Therapy Intervention in Patients With Complex Needs to Improve Social Reintegration

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.

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Key information

Conditions

Rehabilitation Occupational Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Santa Maria Nuova

Reggio Emilia, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Complex impatient
  • Admitted to AUSL-IRCCS/UO MFR

Exclusion criteria

  • Language barriers
  • Severe cognitive impairment
  • Psychiatric disorders
  • Domiciled in a protected facility at the time of admission

Treatment and study plan

Occupational Therapy

Other

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 Care

Other

Usual care consists in rehabilitation treatment delivered by a multidisciplinary team

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

  5. 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

    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.

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

Efficacy of Occupational Therapy in the Rehabilitation of Complex Patients: Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2018
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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