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The remote self-assessment of vital capacity in patients with MND

The remote self-assessment of vital capacity in patients with MND - RESAVICA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49485
Enrollment
30
Registered
2020-06-12
Start date
2020-08-24
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

ALS Amyotrofic Lateral Sclerosis

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. 18 years or older 2. Diagnosed with motor neuron disease (MND): amyotrophic lateral sclerosis (ALS), progressive muscular atrophy (PMA) or primary lateral sclerosis (PLS). 3. Able to perform a respiratory function test with or without caregiver assistance

Exclusion criteria

Exclusion criteria: 1. Tracheostomy Ventilation 2. Severe cognitive impairment

Design outcomes

Primary

MeasureTime frame
The mean difference between the supervised VC*s and the self-assessed VC*s, and the standard deviation of the difference (validity).

Secondary

MeasureTime frame
- Within patient variability of the self-assessed VC during follow-up (reliability). - Feasibility of a 4-weekly home-monitoring protocol. o Adherence: number of completed home assessments divided by total number of home assessments. o Acceptability: Patients* perspectives on the burden, frequency and difficulty of the home assessments.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)