NCT03989388

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

1.8 years

First QC Date

June 13, 2019

Last Update Submit

June 17, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • SF-36 Health Questionnaire

    Evaluation of subjective health perception. Variables: * Eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. * Physical component summary (Mean scores of four domains: physical functioning, role limitations caused by physical health problems, bodily pain, and general health) (Range 0-100) * Mental component summary scores (Mean scores of four domains: role limitations caused by emotional problems, vitality, social functioning, and mental health) (Range 0-100)

    30 minutes

  • Roles Checklist

    Past, present and future occupational roles (Part 1 of Roles Checklist). Variables: \- Number of roles in each period (Range 0-10).

    20 minutes

  • Focus groups

    Qualitative data: Perceived learning and emotions

    1 hour

  • Participant diary

    Perceived learning and emotions in a participant diary after sessions

    2 hours

Study Arms (2)

Intervention Group

EXPERIMENTAL

Occupational Self-Analysis Programme

Behavioral: Occupational self-analysis

Control group

ACTIVE COMPARATOR

Vocational guidance or usual rehabilitation (in the case of ABI participants)

Behavioral: Vocational guidanceBehavioral: Usual Rehabilitation

Interventions

The "Occupational Self-Analysis" program provides participants with a space where they can learn to analyse the barriers and supports for occupational participation.

Intervention Group

To explore participant´s job interests and learned how to find a job and define a professional profile.

Control group

Usual rehabilitation: occupational therapy and/or physiotherapy.

Control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Basic skills such as writing, reading or calculation

You may not qualify if:

  • Unsuitable social behaviour
  • Participants with Acquired Brain Injury:
  • \- Members of an association for people with neurological impairment.
  • Behavioral problems
  • Problems speaking or understanding.
  • Students:
  • \- Occupational therapy student.
  • Absenteeism
  • Lack of suitable social behavior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asociación de Daño Cerebral de Málaga (ADACEMA)

Málaga, 29004, Spain

Location

Universidad Católica San Antonio de Murcia

Murcia, 30107, Spain

Location

Related Publications (1)

  • Fernandez-Solano AJ, Del Bano-Aledo ME, Rodriguez-Bailon M. From thinking to acting: occupational self-analysis tools for use with people with intellectual disability. A pilot study. J Intellect Disabil Res. 2019 Sep;63(9):1086-1096. doi: 10.1111/jir.12621. Epub 2019 Apr 24.

    PMID: 31017354BACKGROUND

MeSH Terms

Conditions

Intellectual DisabilityBrain InjuriesStroke

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

Study Officials

  • Ana Judit Fernández-Solano, PhD

    Universidad Católica San Antonio de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 18, 2019

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations