Trial Outcomes & Findings for Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage (NCT NCT03911752)

Results Overview

12 semi-structured interviews Qualitative data analysis - Theoretical concept saturation and thematic analyses.

Recruitment status

COMPLETED

Target enrollment

12 participants

Primary outcome timeframe

2 months

Results posted on

2019-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	People With Acquired Brain Injury People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).	Partners of People With Acquired Brain Injury Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).	Relatives of People With Acquired Brain Injury Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
Overall Study STARTED	8	2	2
Overall Study COMPLETED	8	2	2
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	People With Acquired Brain Injury n=8 Participants People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).	Partners of People With Acquired Brain Injury n=2 Participants Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).	Relatives of People With Acquired Brain Injury n=2 Participants Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Spain	8 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	12 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Transcription, listening and categorizing the speaking of participants from their answers to the interviews.

12 semi-structured interviews Qualitative data analysis - Theoretical concept saturation and thematic analyses.

Outcome measures

Outcome measures
Measure	People With Acquired Brain Injury n=8 Participants People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).	Partners of People With Acquired Brain Injury n=2 Participants Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).	Relatives of People With Acquired Brain Injury n=2 Participants Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
Number of Participants Who Felt The Approach to Sexuality During Occupational Therapy is Relevant	8 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Interviews

The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used. The COPM measures performance and satisfaction in self-care, productivity and leisure from the client's perspective Areas of everyday living explored during the interview include self-care, productivity or leisure and the occupational performance problems experienced in everyday living are identified. In step two, the client is asked to rate the importance of each of the occupations to his/her life using a 10-point rating scale. In the third step, the client chooses up to five of the most important problems identified in step two. In step four, the client is asked to use a 10 point scale to rate their own level of performance and satisfaction with performance for each of the five problems. These typically range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.

Outcome measures

Outcome measures
Measure	People With Acquired Brain Injury n=8 Participants People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).	Partners of People With Acquired Brain Injury n=2 Participants Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).	Relatives of People With Acquired Brain Injury n=2 Participants Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
Number of Participants That Identified Having Occupational Priorities Activities of Daily Living	8 Participants	2 Participants	2 Participants
Number of Participants That Identified Having Occupational Priorities Work and productivity	5 Participants	1 Participants	1 Participants
Number of Participants That Identified Having Occupational Priorities Leisure	7 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Interviews. Data were not collected for Partners and Relatives because they had not any consequences in their performance due to an Acquired Brain Injury.

The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used. The client chooses up to five of the most important problems identified in his/her daily life, and he/she is asked to use a 10 point scale to rate their own level of performance. These typically range between 1 and 10, where 1 indicates poor performance while 10 indicates very good performance.

Outcome measures

Outcome measures
Measure	People With Acquired Brain Injury n=8 Participants People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).	Partners of People With Acquired Brain Injury Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).	Relatives of People With Acquired Brain Injury Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
Number of Participants With Problems in Performance in His/Her Daily Life Activities of Daily Living	8 Participants	—	—
Number of Participants With Problems in Performance in His/Her Daily Life Work and productivity	4 Participants	—	—
Number of Participants With Problems in Performance in His/Her Daily Life Leisure	5 Participants	—	—

PRIMARY outcome

Timeframe: 2 months

Population: Interviews. Data were not collected for Partners and Relatives because they had not any consequences in their performance due to an Acquired Brain Injury.

The semi-structured interview Canadian Measure of Occupational Performance (CMOP) was used. The client is asked to use a 10 point scale to rate their own satisfaction during the performance of activities of daily life. Satisfaction refers to the self-perception of the results derived from doing any activity of daily life. These typically range between 1 and 10, where 1 indicates low satisfaction, respectively, while 10 indicates high satisfaction.

Outcome measures

Outcome measures
Measure	People With Acquired Brain Injury n=8 Participants People with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=8).	Partners of People With Acquired Brain Injury Partners of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).	Relatives of People With Acquired Brain Injury Relatives of people with Acquired Brain Injury in a subacute stage who go to occupational therapy (N=2).
Number of Participants Who Are Satisfied With Performance in Areas of Everyday Living. Activities of Daily Living	4 Participants	—	—
Number of Participants Who Are Satisfied With Performance in Areas of Everyday Living. Work and productivity	5 Participants	—	—
Number of Participants Who Are Satisfied With Performance in Areas of Everyday Living. Leisure	3 Participants	—	—

Adverse Events

People With Acquired Brain Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Partners of People With Acquired Brain Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Relatives of People With Acquired Brain Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thais Pousada García

University of A Coruña

Phone: +34 981 167 000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place