- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03989388
Occupational Self-Analysis Programme
Occupational Self-Analysis Programme in Participants With Intellectual Disabilities, Acquired Brain Injury and Students
Introduction There is a growing tendency from Occupational Therapy towards the use of programs based on occupation, which, through significant occupational participation, have shown to obtain beneficial results maintained over time in its participants. For this, these programs carry out processes of occupational self- analysis in which people reflect on the daily activities they usually perform so that they can generate modifications towards more satisfactory routines. However, and despite their proven benefits, these programs have been conducted mainly on older people and in cultural contexts other than Spanish.
The "Occupational Self-Analysis" program, developed in the Spanish context, provides participants with a space where they can learn to analyse the barriers and supports for occupational participation and thus achieve a more significant occupational performance.
Objectives The objective of this study was to assess the effectiveness of the "Occupational Self-Analysis" program on the subjective perception of health and the number of roles in people with and without disabilities. In the same way, the purpose was to analyse the increase or modification of the performance in the Activities of the Daily Life that the participants did, and to know how the social environment supports the individual participation of the participants in meaningful activities.
Method The implementation of the "Occupational Self-Analysis" program was carried out in 3 different populations; people with intellectual disability, people with acquired brain injury (ABI) and University students. The intervention was performed by comparing it with a control group (vocational guidance or usual rehabilitation in the caso of ABI participants). In people with intellectual disability, the experimental group consisted of 12 participants and the control one of 13. In people with ABI, the experimental group involved 5 participants and the control, 7. In university students, the experimental group involved 7 and the control 7. The SF-36 Health Questionnaire was used for the evaluation of subjective health perception and the Roles Checklist (Part 1) to evaluate the number of roles they play in the present and the future. All of them underwent a final focus group and the diary were they wrote their learning and emotions was analyzed to assess the benefits of the program.
Przegląd badań
Status
Warunki
Szczegółowy opis
Results A positive trend was observed in all dimensions of the SF-36 Health Questionnaire in people with intellectual disability and ABI. In the experimental group of people with intellectual disability the improvements were significant compared to the control group in the dimensions of role limitations due to physical problems (Z = -2.41, p = .016), role limitations due to emotional problems (Z = - 1.99; p = .046), social function (Z = -3.35; p = .001) and the accumulated scores of the mental component (Z = -2.66; p = .008). On the other hand, the ABI experimental group obtained significant improvements in vitality after the intervention (Z = -2.20, p = .028), not finding statistically significant improvements compared to the control group.
With respect to the number of roles internalized, both the experimental group with intellectual disability and the one presenting ABI experienced a marginally significant increase in the number of roles that participants wanted to develop in the future after taking part in the program.
Both in people with intellectual disability, ABI and students, the program improved the involvement in meaningful activities through the inclusion of new occupations, modification of previous habits or the transformation of solitary activities into social participation activities. In addition, the participants increased their awareness of those factors that influenced their participation in meaningful activities. This meant becoming aware of aspects related to volition, habituation, personal abilities and the environment.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Murcia, Hiszpania, 30107
- Universidad Católica San Antonio de Murcia
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Málaga, Hiszpania, 29004
- Asociación de Daño Cerebral de Málaga (ADACEMA)
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Participants with Intellectual disabilities:
Inclusion Criteria:
- Basic skills such as writing, reading or calculation
Exclusion Criteria:
-Unsuitable social behaviour
Participants with Acquired Brain Injury:
Inclusion Criteria:
- Members of an association for people with neurological impairment.
Exclusion Criteria:
- Behavioral problems
- Problems speaking or understanding.
Students:
Inclusion Criteria:
- Occupational therapy student.
Exclusion Criteria:
- Absenteeism
- Lack of suitable social behavior
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Intervention Group
Occupational Self-Analysis Programme
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The "Occupational Self-Analysis" program provides participants with a space where they can learn to analyse the barriers and supports for occupational participation.
|
Aktywny komparator: Control group
Vocational guidance or usual rehabilitation (in the case of ABI participants)
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To explore participant´s job interests and learned how to find a job and define a professional profile.
Usual rehabilitation: occupational therapy and/or physiotherapy.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
SF-36 Health Questionnaire
Ramy czasowe: 30 minutes
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Evaluation of subjective health perception. Variables:
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30 minutes
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Roles Checklist
Ramy czasowe: 20 minutes
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Past, present and future occupational roles (Part 1 of Roles Checklist). Variables: - Number of roles in each period (Range 0-10). |
20 minutes
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Focus groups
Ramy czasowe: 1 hour
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Qualitative data: Perceived learning and emotions
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1 hour
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Participant diary
Ramy czasowe: 2 hours
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Perceived learning and emotions in a participant diary after sessions
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2 hours
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Ana Judit Fernández-Solano, PhD, Universidad Católica San Antonio de Murcia
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Occupational Self-Analysis2016
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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