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Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03806647
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
The research is aimed to explore the needs of clinical patients and their caregiver,so as to provide suggestions to the designer of the communication system.

Condition or disease
Amyotrophic Lateral Sclerosis

Detailed Description:
To promote and develop a smart communication system is helpful to patients with amyotrophic lateral sclerosis (ALS),especially for stage 3 and stage 4 (late stage). Through the needs assessment, the research is aimed to explore the needs of clinical patients and their caregiver,so as to provide suggestions to the designer of the communication system.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Taipei Veterans General Hospital
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : September 1, 2020





Primary Outcome Measures :
  1. Amyotrophic Lateral Sclerosis Supportive Care Needs (ALSSCN) [ Time Frame: 2018.10.01~2020.04.31 ]
    The ALSSCN consisted of 37 items with seven domains: physical, psychological, emotional, spiritual, social, informational, and practical needs.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with ALS were recruited from ALS clinics(Taipei Veterans General Hospital, Taiwan, R.O.C),20 participants. Participants were eligible for this study if they were diagnosed with definite, probable, probable laboratory-supported, or possible ALS according to the criteria (Brooks et al., 2000).
Criteria

Inclusion Criteria:

  • Clinical diagnosis of ALS
  • Taiwanese and used traditional Chinese(Mandarin).
  • If they were older than age 20 years.

Exclusion Criteria:

  • Frontotemporal dementia, severe depression, or schizophrenia.
  • If they cannot complete the questionnaire with researchers or family members help.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806647


Contacts
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Contact: Si Huei Li 886-2871-2121 ext 2931 lableesihuei@gmail.com
Contact: Cheng Liang Chou 886-2871-2121 ext 7361 cl_chou@vghtpe.gov.tw

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, TW, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03806647    
Other Study ID Numbers: 2018-09-001A-1
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Amyotrophic lateral sclerosis, ALS, communication, needs
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases