NCT05299372

Brief Summary

This is a feasibility study of telemonitoring system for people with MND/ALS, who are on NIV, via a call centre operated by a local clinical commissioning group.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

September 21, 2021

Last Update Submit

March 18, 2022

Conditions

Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Keywords

non-invasive ventilationTelehealthTelemonitoring

Outcome Measures

Primary Outcomes (2)

  • Acceptability - Qualitative data through semi-structured interviews and focus groups

    Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.

    Qualitative data will be conducted at 3-month

  • Usability - Qualitative data through semi-structured interviews and focus groups

    Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.

    Qualitative data will be conducted at 3-month

Secondary Outcomes (11)

  • Patient Reported Outcome Measurement - Neurological Fatigue Index for MND

    Baseline and then 6-weekly up to 24 weeks

  • Patient Reported Outcome Measurement - Epworth Sleepiness Scale

    Baseline and then 6-weekly up to 24 weeks

  • Patient Reported Outcome Measurement - Dyspnoea-12

    Baseline and then 6-weekly up to 24 weeks

  • Patient Reported Outcome Measurement - revised Amyotrophic Lateral Sclerosis Functional Rating Scale

    Baseline and at 3-month and 6-month

  • Patient Reported Outcome Measurement - Hospital Anxiety and Depression Scale

    Baseline and at 3-month and 6-month

  • +6 more secondary outcomes

Study Arms (1)

Telemonitoring via Careportal®

OTHER

Participants will be prompted by the device to answer two sets of questions every week: 10 items (1 nested) in the morning and 16 items (4 nested) in the evening. Also on a weekly basis, patients will be prompted to perform overnight oximetry test, and upload patient-ventilator interaction data (PVI) via Careportal®.

Other: Telemonitoring via Careportal®

Interventions

Telemonitoring via Careportal®OTHER

The question sets and overnight oximetry results will be monitored and screened by a call centre commissioned by the Liverpool Clinical Commissioning Group (LCCG). The call centre will screen the weekly data and contact clinicians where appropriate (i.e. NIV team, MND specialist nurse, or patient's GP). PVI data will be examined by NIV physiotherapists, where required, following the contact from LCCG to ensure the maximum benefits of NIV to patients.

Telemonitoring via Careportal®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of MND with respiratory muscle weakness
  • Adults who are capable of informed consent
  • Patients for whom we anticipate survival of 6 months or more
  • Able to communicate with an interviewer. Alternative communication methods will be used as required in order to mitigate communication difficulties.

You may not qualify if:

  • Patients who have declined NIV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ando H, Ashcroft-Kelso H, Halhead R, Young CA, Chakrabarti B, Levene P, Cousins R, Angus RM. Incorporating self-reported questions for telemonitoring to optimize care of patients with MND on noninvasive ventilation (MND OptNIVent). Amyotroph Lateral Scler Frontotemporal Degener. 2019 Aug;20(5-6):336-347. doi: 10.1080/21678421.2019.1587630. Epub 2019 Mar 26.

    PMID: 30912468BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Robert M Angus, MRCP, FRCP

    Liverpool University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hikari Ando, PhD

CONTACT

0151529hikari.ando@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

March 29, 2022

Study Start

April 25, 2022

Primary Completion

October 31, 2022

Study Completion

December 31, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03