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

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT03806634
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Last Update Submitted: 2019-01-14
• Study First Posted: 2019-01-16
• Last Update Posted: 2019-01-16
• Study Start: 2019-03-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
System Usability Scale	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

Name	Time	Method
Taiwanese Depression Questionnaire, TDQ	2019.04.01~2019.06.30	The TDQ is a culturally relevant questionnaire, which is adaptable for screening depressive people in the local communities.
Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, ALSSQOL-R	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.
Caregiver Burden Scale	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.

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, TW, Taiwan