NCT04346303

Brief 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. 1.Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.
  2. 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 15, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

March 31, 2020

Last Update Submit

April 14, 2020

Conditions

Keywords

Short-term Interactive Video GamesCommunity Patients with Mental Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Body Mass Index

    5 Weeks

  • Waist-hip ratio

    5 Weeks

  • 10-m walking time at comfortable

    5 Weeks

  • 10-m walking time at maximum

    5 Weeks

  • Get Up and Go test

    5 Weeks

  • +4 more secondary outcomes

Study Arms (1)

Short-term Interactive Video Games

OTHER

Short-term video games will be applied to patients with mental illness who are staying in communities. Games will be applied in a group-activity format with 8 to 12 patients in each session. The interventions will be conducted at a two sessions per week for a 3-week long period. There are 3 time points for data collection, including 2-weeks before the intervention, the week before the intervention, and the week after the intervention. Each patient will be his/her own controlled comparison.

Other: Short-term Interactive Video Games

Interventions

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.

Short-term Interactive Video Games

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Chang Jung-Chen, PhD

    National Taiwan University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Jung-Chen, PhD

CONTACT

Hsu Fang-Chi, University

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 15, 2020

Study Start

March 16, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 15, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations