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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04346303
Other study ID # 202001106RIND
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 16, 2020
Est. completion date December 31, 2020

Study information

Verified date March 2020
Source National Taiwan University Hospital
Contact Chang Jung-Chen, PhD
Phone (02)223123456
Email jungchenchang@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:

1. Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.

2. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).

3. After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.


Description:

The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:

1. Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.

2. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).

3. After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.

Primary Outcome Measure:

The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form) After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life.

[Time Frame: 5 Weeks]

Secondary Outcome Measures:

Body Mass Index Measuring height and weight [Time Frame: 5 Weeks]

Waist-hip ratio Measuring the ratio of waist to hip [Time Frame: 5 Weeks]

10-m walking time at comfortable Measuring the 10-m walking time at comfortable [Time Frame: 5 Weeks]

10-m walking time at maximum Measuring the 10-m walking time at maximum [Time Frame: 5 Weeks]

Get Up and Go test Measuring the Get Up and Go test [Time Frame: 5 Weeks]

5 times sit-to-stand test Measuring the 5 times sit-to-stand test [Time Frame: 5 Weeks]

Hierarchy of the Care Required This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function.

[Time Frame: 5 Weeks]

CHQ-12 (Chinese Health Questionnaire) This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms.

[Time Frame: 5 Weeks]

Short FES-I (Chinese version of the Falls Efficacy Scale ) This is a 7-item scale to assess patient's vulnerability to fall. [Time Frame: 5 Weeks]


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- The diagnosis conforms to the international classification standards for the diagnosis of dysphoria or bipolar disorder.

- Be older than 20 years old.

- those who have a clear sense and can communicate.

- You can read the instructions carefully, and after you explain, you are willing to participate in the research plan and fill out the consent form.

- The judges of the researchers can independently answer the interview questionnaires of this research and perform short-term interactive video game players.

- At present, you can go out, make friends, take care of yourself, and fully exercise your rights. You have the full capacity of an adult and have not been restricted by any laws. Therefore, you do not need to obtain an additional legal agent to participate in this study Sign the consent form.

Exclusion Criteria:

- People with difficulties in cognitive understanding, such as those who cannot communicate or suffer from cognitive impairments, such as Alzheimer's disease.

- Those who have obvious obstacles to the physical function of their limbs, who are unable to participate in sports video games.

- Slow development or lack of moderate intelligence may affect the understanding of interviews or participation in activities.

- The physical and mental condition has been unstable in the past two weeks, such as instability of vital signs or obvious impaired sense of reality, obvious symptoms of delusions or hallucinations, etc., cannot be interviewed or coordinated with activities.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Short-term Interactive Video Games
Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2). After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form) After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life. 5 Weeks
Secondary Body Mass Index Measuring height and weight 5 Weeks
Secondary Waist-hip ratio Measuring the ratio of waist to hip 5 Weeks
Secondary 10-m walking time at comfortable Measuring the 10-m walking time at comfortable 5 Weeks
Secondary 10-m walking time at maximum Measuring the 10-m walking time at maximum 5 Weeks
Secondary Get Up and Go test Measuring the Get Up and Go test 5 Weeks
Secondary 5 times sit-to-stand test Measuring the 5 times sit-to-stand test 5 Weeks
Secondary Hierarchy of the Care Required This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function. 5 Weeks
Secondary CHQ-12 (Chinese Health Questionnaire) This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms. 5 Weeks
Secondary Short FES-I (Chinese version of the Falls Efficacy Scale ) This is a 7-item scale to assess patient's vulnerability to fall. 5 Weeks
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