CClinicalTrials.gg
Status unknownNCT03806634Updated Jan 16, 2019

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

An observational study in Amyotrophic Lateral Sclerosis, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.

Sponsored by Taipei Veterans General Hospital, Taiwan · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20
Ages
20 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • Amyotrophic lateral sclerosis, ALS, communication, needs
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In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's planned enrollment of 20 is below the median of 109 across 217 observational studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. System Usability Scale

    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.

    Time frame: 2019.04.01~2019.06.30

Secondary outcomes

  1. Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, ALSSQOL-R

    ALSSQOL-R is a 50 item instrument that measures overall quality of life (QOL) and six specific domains for individuals with ALS.

    Time frame: 2019.04.01~2019.06.30

  2. Taiwanese Depression Questionnaire, TDQ

    The TDQ is a culturally relevant questionnaire, which is adaptable for screening depressive people in the local communities.

    Time frame: 2019.04.01~2019.06.30

  3. Caregiver Burden Scale

    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.

    Time frame: 2019.04.01~2019.06.30

07

Study locations

1 site
  • Taipei Veterans General Hospital
    Taipei, TW 11217, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03806634
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
Jan 16, 2019
Start date
Mar 1, 2019 (estimated)
Primary completion
Jul 31, 2020 (estimated)
Completion
Sep 1, 2020 (estimated)
Last update
Jan 16, 2019

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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