Development of a remote, patient-centric, clinical trial model using digital healthcare technology

Development of a remote, patient-centric, clinical trial model using digital healthcare technology - TRICALS-ORIGIN

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53924

Enrollment

100

Registered

2022-08-23

Start date

2023-01-27

Completion date

Unknown

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALS, Amyotrofic Lateral Sclerosis ALS

Interventions

Digital at home monitoring of body&nbsp

weight, spirometry, accelerometery, audio-visual speech measures, and clinical&nbsp

progression.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis with ALS according to the Gold Coast criteria 2. ENCALS risk profile ranging between -6 and -2 3. 18 years or older 4. Able to provide informed consent

Exclusion criteria

Exclusion criteria: Fulfilling the criteria for respiratory insufficiency (non-invasive ventilation use >22 hours per day for 10 consecutive days or having a tracheostomy)

Design outcomes

Primary

Measure	Time frame
Patient adherence defined as the number of completed measurements divided by the total number of assessments. Adherence will be assessed per parameter.	—

Secondary

Measure	Time frame
Overall survival, defined as time to death from any cause or respiratory insufficiency (RI; defined as tracheostomy or the use of non-invasive ventilation for >22 h per day for >=10 consecutive days). Daily functioning, defined as mean change from baseline in ALSFRS-R total score and PRO-ALS score. Respiratory function, defined as mean change from baseline in VC (% predicted of normal according to the GLI-2012 reference standard) as measured by spirometry, and MND-DS. Physical function, defined as mean change from baseline in vertical variation as assessed by accelerometry. Bulbar function, defined as mean change from baseline in acoustic measures (e.g., rate, duration, voicing) and visual measures (e.g., higher order statistics of the jaw and lip) as assessed by audio-visual speech measures. Gastrostomy placement, defined as time-to-gastrostomy since enrollment. Non-invasive ventilation use, defined as time-to-non-invasive ventilation initiation since enrollment. Body weight, defined as mean change from baseline in kilograms. Clinical disease stage, defined as mean time spent in each stage of the King*s and ALS Milano-Torino staging systems. Patient burden and user-experience as assessed by custom-made questionnaire. Patient reported outcomes measures as assessed by global assessment ratings in a custom-made questionnaire.	—

Measure

Time frame

Overall survival, defined as time to death from any cause or respiratory insufficiency (RI; defined as tracheostomy or the use of non-invasive ventilation for >22 h per day for >=10 consecutive days). Daily functioning, defined as mean change from baseline in ALSFRS-R total score and PRO-ALS score. Respiratory function, defined as mean change from baseline in VC (% predicted of normal according to the GLI-2012 reference standard) as measured by spirometry, and MND-DS. Physical function, defined as mean change from baseline in vertical variation as assessed by accelerometry. Bulbar function, defined as mean change from baseline in acoustic measures (e.g., rate, duration, voicing) and visual measures (e.g., higher order statistics of the jaw and lip) as assessed by audio-visual speech measures. Gastrostomy placement, defined as time-to-gastrostomy since enrollment. Non-invasive ventilation use, defined as time-to-non-invasive ventilation initiation since enrollment. Body weight, defined as mean change from baseline in kilograms. Clinical disease stage, defined as mean time spent in each stage of the King*s and ALS Milano-Torino staging systems. Patient burden and user-experience as assessed by custom-made questionnaire. Patient reported outcomes measures as assessed by global assessment ratings in a custom-made questionnaire.

—

Countries

Netherlands

Contacts

Public ContactLianne C.M. Botman

Universitair Medisch Centrum Utrecht

c.m.botman@umcutrecht.nl0614616158

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026