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Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 2)

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. Identifier: NCT03806634
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
The research is aimed to asses the validity of the communication system improving the quality of life and the degree of sanctification of clinical patients and their caregiver.

Condition or disease
Amyotrophic Lateral Sclerosis

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : September 1, 2020

Primary Outcome Measures :
  1. System Usability Scale [ Time Frame: 2019.04.01~2019.06.30 ]
    It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. And also we can know the sanctification of the patient with ALS and their caregiver.

Secondary Outcome Measures :
  1. Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, ALSSQOL-R [ Time Frame: 2019.04.01~2019.06.30 ]
    ALSSQOL-R is a 50 item instrument that measures overall quality of life (QOL) and six specific domains for individuals with ALS.

  2. Taiwanese Depression Questionnaire, TDQ [ Time Frame: 2019.04.01~2019.06.30 ]
    The TDQ is a culturally relevant questionnaire, which is adaptable for screening depressive people in the local communities.

  3. Caregiver Burden Scale [ Time Frame: 2019.04.01~2019.06.30 ]
    The burden experienced by family caregivers is the most important caregiver-related variable in care at home of a chronically-ill person. The extent of subjective burden has significant impact on the emotional and physical health of the family caregiver, and even influences the mortality of spouse caregivers. It affects the way the family caregiver deals with the care-receiver and determines the time of institutionalization.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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).

Inclusion Criteria:

  • Escorial revised criteria (Brooks et al., 2000),The diagnosis of ALS requires:

(A) the presence of:

  • (A:1) evidence of lower motor neuron (LMN) degeneration by clinical, electrophysiological or neuropathologic examination (A:2) evidence of upper motor neuron (UMN) degeneration by clinical examination, and
  • (A:3) progressive spread of symptoms or signs within a region or to other regions, as determined by history or examination, together with: (B) the absence of (B:1) electrophysiological or pathological evidence of other disease processes that might explain the signs of LMN and/or UMN degeneration, and (B:2) neuroimaging evidence of other disease processes that might explain the observed clinical and electrophysiological signs.

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

Exclusion Criteria:

  • If they had been diagnosed with frontotemporal dementia, severe depression, or schizophrenia.
  • If they cannot see the communication board after correction.
  • 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 identifier (NCT number): NCT03806634

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Contact: Si Huei Li 886-2871-2121 ext 2931
Contact: Cheng Liang Chou 886-2871-2121 ext 7361

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Taipei Veterans General Hospital Not yet recruiting
Taipei, TW, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan Identifier: NCT03806634    
Other Study ID Numbers: 2018-09-001A-2
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: September 2018
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
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases