Amyotrophic Lateral SclerosisNCT03806647
Development and Needs Assessment and Efficiency of Smart Communication System for Patients With ALS (Part 1)
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 explore the needs of clinical patients and their caregiver,so as to provide suggestions to the designer of the communication system. 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 Sep 2018to 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
- Clinical diagnosis of ALS
- Taiwanese and used traditional Chinese(Mandarin).
- If they were older than age 20 years.
Who cannot join
- Frontotemporal dementia, severe depression, or schizophrenia.
- If they cannot complete the questionnaire with researchers or family members help.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, TW, 11217
About this study
Official title: Taipei Veterans General Hospital
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.
Read the 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.
- 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.
Amyotrophic Lateral Sclerosis Supportive Care Needs (ALSSCN)
The ALSSCN consisted of 37 items with seven domains: physical, psychological, emotional, spiritual, social, informational, and practical needs.
Measured: 2018.10.01~2020.04.31
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 Sep 2018
- Primary completion1 Apr 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
- NCT03806647
- Sponsor's protocol ID
- 2018-09-001A-1
- Status last verified
- Jan 2019
- First submitted
- 14 Jan 2019
- Last updated
- 18 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 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taipei Veterans General Hospital
- ClinicalTrials.gov ID
- NCT03806647
- Acronym / sponsor ID
- 2018-09-001A-1
- 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 Sep 2018 (actual)
- Primary completion
- 1 Apr 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 explore the needs of clinical patients and their caregiver,so as to provide suggestions to the designer of the communication system.
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.
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 (3 listed)
- Clinical diagnosis of ALS
- Taiwanese and used traditional Chinese(Mandarin).
- If they were older than age 20 years.
Key exclusion criteria (2 listed)
- Frontotemporal dementia, severe depression, or schizophrenia.
- 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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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 3 inclusion and 2 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 18 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?
Amyotrophic Lateral Sclerosis Supportive Care Needs (ALSSCN) (time frame: 2018.10.01~2020.04.31). 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 18 Jan 2019.