Amyotrophic Lateral SclerosisNCT03806634
Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 2)
An observational study of Amyotrophic Lateral Sclerosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2019to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Escorial revised criteria (Brooks et al., 2000),The diagnosis of ALS requires:
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis, ALS, communication, needs
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Communication
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2019.04.01~2019.06.30
Secondary outcomes (3)
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.
Measured: 2019.04.01~2019.06.30
Taiwanese Depression Questionnaire, TDQ
The TDQ is a culturally relevant questionnaire, which is adaptable for screening depressive people in the local communities.
Measured: 2019.04.01~2019.06.30
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.
Measured: 2019.04.01~2019.06.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start1 Mar 2019 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806634
- Sponsor's protocol ID
- 2018-09-001A-2
- Status last verified
- Sep 2018
- First submitted
- 14 Jan 2019
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital
- ClinicalTrials.gov ID
- NCT03806634
- Acronym / sponsor ID
- 2018-09-001A-2
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis, ALS, communication, needs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- Escorial revised criteria (Brooks et al., 2000),The diagnosis of ALS requires:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, ALSSQOL-R
Time frame: 2019.04.01~2019.06.30
Taiwanese Depression Questionnaire, TDQ
Time frame: 2019.04.01~2019.06.30
Caregiver Burden Scale
Time frame: 2019.04.01~2019.06.30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Si Huei Li (886-2871-2121 ext. 2931, lableesihuei@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (time frame: 2019.04.01~2019.06.30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.