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

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.

Study Overview

• Status: Unknown
• Conditions: Amyotrophic Lateral Sclerosis

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Taiwan
  • TW
    • Taipei, TW, Taiwan, 11217
      • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Amyotrophic lateral sclerosis, ALS, communication, needs
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: 2018-09-001A-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No