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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Department of Physical Medicine & Rehabilitation, Taipei Veterans General Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03806634
• Other study ID #: 2018-09-001A-2
• Status: Not yet recruiting
• Start date: March 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: September 2018
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Si Huei Li
• Phone: 886-2871-2121
• Email: lableesihuei[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 1, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei	TW

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2019.04.01~2019.06.30
Secondary	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.	2019.04.01~2019.06.30
Secondary	Taiwanese Depression Questionnaire, TDQ	The TDQ is a culturally relevant questionnaire, which is adaptable for screening depressive people in the local communities.	2019.04.01~2019.06.30
Secondary	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.	2019.04.01~2019.06.30