Trial Outcomes & Findings for The Outcomes of Seamless ADL Training Between Occupational Therapist and Nurse in Stroke Patients (NCT NCT02361307)

Results Overview

Normalized gain The raw score from the self-care checklist for dressing and washing oneself was used to calculate the normalized gain. Because stroke patients had varying scores for their initial dressing and washing oneself abilities, their possible window of improvement could be limited by the "floor to ceiling" effect. Therefore, it was considered that their improvements should be assessed by the normalized gain, which was introduced by Hake as a rough measure of the effectiveness of a training course and has since become the standard method for reporting scores. Hake defined normalized gain (g) as the ratio of the actual gain to the maximum possible gain as given in the equation: Normalized gain (g) = (post-training) - (pre-training) / (maximum score) - (pre-training) With a possible value between 0.0-1.0, the normalized gain can be divided into 3 levels: ''high-g'' for g ≥ 0.7, ''medium-g'' for 0.3 ≤ g ˂0.7, and ''low-g'' for g ˂ 0.3 The higher score means a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

2 weeks

Results posted on

2021-08-10

Participant Flow

Participant milestones

Participant milestones
Measure	Conventional ADL Training The control group receive the conventional ADL training program	Seamless ADL Training The experimental group receive the seamless ADL training program which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training.
Overall Study STARTED	18	18
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Conventional ADL Training The control group receive the conventional ADL training program	Seamless ADL Training The experimental group receive the seamless ADL training program which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training.
Overall Study Unstable medical condition.	0	1

Baseline Characteristics

The Outcomes of Seamless ADL Training Between Occupational Therapist and Nurse in Stroke Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional ADL Training n=18 Participants The control group receive the conventional ADL training programme Conventional ADL training: The control group receive the conventional ADL training programme	Seamless ADL Training n=17 Participants The experimental group receive the seamless ADL training programme which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training. Seamless ADL training: The experimental group receive the seamless ADL training which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training	Total n=35 Participants Total of all reporting groups
Age, Continuous	59.4 years STANDARD_DEVIATION 10.9 • n=5 Participants	57.1 years STANDARD_DEVIATION 10.3 • n=7 Participants	58.3 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment Thailand	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Self-care score	31.2 units on a scale STANDARD_DEVIATION 7.6 • n=5 Participants	29.6 units on a scale STANDARD_DEVIATION 6.7 • n=7 Participants	30.4 units on a scale STANDARD_DEVIATION 7.2 • n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Normalized gain The raw score from the self-care checklist for dressing and washing oneself was used to calculate the normalized gain. Because stroke patients had varying scores for their initial dressing and washing oneself abilities, their possible window of improvement could be limited by the "floor to ceiling" effect. Therefore, it was considered that their improvements should be assessed by the normalized gain, which was introduced by Hake as a rough measure of the effectiveness of a training course and has since become the standard method for reporting scores. Hake defined normalized gain (g) as the ratio of the actual gain to the maximum possible gain as given in the equation: Normalized gain (g) = (post-training) - (pre-training) / (maximum score) - (pre-training) With a possible value between 0.0-1.0, the normalized gain can be divided into 3 levels: ''high-g'' for g ≥ 0.7, ''medium-g'' for 0.3 ≤ g ˂0.7, and ''low-g'' for g ˂ 0.3 The higher score means a better outcome.

Outcome measures

Outcome measures
Measure	Conventional ADL Training n=18 Participants The control group receive the conventional ADL training program Conventional ADL training: The control group receive the conventional ADL training program	Seamless ADL Training n=17 Participants The experimental group receive the seamless ADL training programme which occupational therapists and nurse work with effective communication and cooperate in dressing and bathing training.
Ability of Dressing and Bathing	0.71 score on a scale Standard Deviation 0.3	0.96 score on a scale Standard Deviation 0.1

Adverse Events

Conventional ADL Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Seamless ADL Training

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

Piyapat Dajpratham

Mahidol University

Phone: 6624197508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place