Telehealth in MND-Research (TIM-R): A Research Database for MND

NCT07132879 | Recruiting DMC

• 2 other identifiers: 187038340577
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to implement the Telehealth in MND system as a research database allowing people with MND to take part in research and provide data remotely (TiM-Research). TiM-Research is an online platform that helps people with MND in the UK take part in research. It brings MND research studies together in one place, making it quick and easy to learn about opportunities to get involved. What's involved? Participants will receive information about a wide range of research studies that they can sign up for. This could include filling out questionnaires that help researchers understand how MND progresses, providing biosamples (e.g. saliva), or taking part in interviews and focus groups about their experiences. Participants can choose which studies they want to take part in. Participants will also receive updates on research results from the UK MND Research Institute. Who can take part? People who live with MND and who are based in the UK can sign up for TiM-Research. To join, participants need a computer, phone, or tablet with an internet connection. A family member or carer can help. Participants' information will be kept secure and confidential. How do participants sign up? Visit the website to find out more or sign up. www.bit.ly/ukmndri-Tim-R.

Conditions

MND (Motor Neurone DIsease)

Outcome Measures

Primary Outcomes (10)

• ALSFRS-r (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale)

  Functional rating of MND symptoms The ALSFRS-R consists of 12 questions, each scored from 0 to 4. Minimum Score: The lowest possible score on the scale is 0, representing the worst performance and a total loss of function across all assessed tasks. Maximum Score: The highest possible score is 48, which indicates a normal level of function. Scoring: A higher score on the scale is a better outcome, as it indicates a greater retention of physical function and a slower progression of the disease. A declining score signifies a worsening of the patient's condition.

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

• Coping Index-ALS

  The Coping Index-ALS (CI-ALS) is a self-report measure used to assess coping abilities in people with amyotrophic lateral sclerosis (ALS). The CI-ALS is a 21-item scale that focuses on two key subscales: "coping by self" and "coping with others." Minimum and Maximum Values: The scale uses a nomogram to convert raw scores into interval-level measures, but the exact minimum and maximum numerical values of the scale are not consistently reported as a single, simple range like the ALSFRS-R. Instead, the focus is on the subscales and the overall pattern of scores. Scoring: A higher score on the CI-ALS generally means a better outcome. A high score indicates a greater use of adaptive, successful coping strategies, which are associated with improved well-being and, in some studies, even longer survival. The scale helps clinicians identify individuals with poor coping mechanisms so they can receive targeted support.

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

• EQ-5D-5L (EuroQol 5-Dimension 5-Level)

  A generic measure of a person's health status. Scale Values and Scoring The EQ-5D-5L assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on five levels of severity. The scores can be interpreted in two main ways: 1\. The Descriptive System The descriptive system generates a 5-digit health profile (e.g., 11111 or 55555), where each digit corresponds to one of the five dimensions. Minimum Value: A score of 11111 represents the best possible health state, with "no problems" in any dimension. Maximum Value: A score of 55555 represents the worst possible health state, with "extreme problems" or being "unable to" in every dimension. Scoring: In this system, a lower score (i.e., a smaller number) indicates a better outcome.

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

• D-12 (Dyspnoea-12)

  D-12 is a patient-reported questionnaire designed to measure the severity of breathlessness by assessing both its physical and emotional components. The D-12 consists of 12 items, each rated on a 4-point scale: 0 (none), 1 (mild), 2 (moderate), or 3 (severe). Minimum Value: The lowest possible score is 0, which indicates no breathlessness in any of the 12 domains. Maximum Value: The highest possible score is 36, representing the maximum possible severity of breathlessness. Scoring: A higher score on the Dyspnoea-12 indicates a worse outcome, as it signifies a greater severity of breathlessness and its associated physical and emotional impacts.

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

• M-HADS-D (Depression subscale of the Hospital Anxiety and Depression Scale)

  Anxiety and depression The M-HADS-D contains seven questions, with each item scored on a 4-point scale ranging from 0 to 3. Minimum Value: The lowest possible score is 0, indicating no symptoms of depression. Maximum Value: The highest possible score is 21, indicating severe depressive symptoms. Scoring: A higher score on the M-HADS-D indicates a worse outcome. The score is interpreted to determine the likelihood and severity of depression, with scores typically categorized as follows: 0-7: Normal 8-10: Borderline or possible depression 11-21: Probable clinical depression

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

• NFI-MND (Neurological Fatigue Index-Motor Neurone Disease)

  Measure of fatigue in people with MND The NFI-MND consists of an 8-item summary scale, as well as separate subscales for "energy" and "weakness." Each item is rated on a scale from 0 to 3. Minimum Value: The lowest possible score on the 8-item summary scale is 0, indicating no fatigue. Maximum Value: The highest possible score on the 8-item summary scale is 24, indicating maximum fatigue. Scoring: A higher score on the NFI-MND indicates a worse outcome, as it signifies a greater level of fatigue.

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

• WHOQoLB (World Health Organization Quality of Life-BREF) -Bref stands for 'brief version'

  The WHOQOL-BREF questionnaire is used to calculate four domain scores and two stand-alone items for overall quality of life and general health. Each item is rated on a 5-point scale. The raw scores are then converted to a transformed score for each domain. Minimum Value: For the four main domains, the transformed scores range from 4 to 20 or, when scaled to be comparable with other measures, 0 to 100. A score of 0 or 4 represents the worst possible quality of life in that domain. Maximum Value: A score of 20 (on the 4-20 scale) or 100 (on the 0-100 scale) represents the best possible quality of life in that domain. Scoring: A higher score on the WHOQOL-BREF indicates a better outcome, meaning a higher quality of life. This applies to both the individual domain scores and the scores for overall quality of life and general health.

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

• MND-SWS (Motor Neurone Disease Social Withdrawal Scale)

  Measure of social withdrawal Scale Values and Scoring The MND-SWS has two versions: a 10-item version and a 15-item version. Both versions assess the frequency and quality of social interactions. Minimum Value: The lowest possible score for the 10-item scale is 0, indicating no social withdrawal. For the 15-item scale, the minimum score is also 0. Maximum Value: The highest possible score for the 10-item scale is 40. For the 15-item scale, the maximum score is 60. A higher score indicates a greater degree of social withdrawal. Scoring: A higher score on the MND-SWS indicates a worse outcome, as it reflects an increase in social withdrawal and a decrease in social engagement.

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

• RSES (Rosenberg Self-Esteem Scale)

  Self-esteem The RSES consists of 10 items, with responses rated on a 4-point Likert scale from "strongly agree" to "strongly disagree." Minimum Value: The lowest possible score is 0, indicating the lowest possible self-esteem. Maximum Value: The highest possible score is 30, indicating the highest possible self-esteem. Scoring: A higher score on the RSES indicates a better outcome, as it reflects a greater level of self-esteem. However, it's worth noting that the scale is often used for descriptive purposes rather than clinical diagnosis, and scores are typically categorized to indicate low, normal, or high self-esteem.

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

• GSE (General Self-efficacy Scale)

  Self-efficacy The GSE has 10 items, and each item is rated on a 4-point Likert scale with responses ranging from "not at all true" to "exactly true". Minimum Value: The lowest possible score is 10, which indicates a low level of self-efficacy. Maximum Value: The highest possible score is 40, which indicates a high level of self-efficacy. Scoring: A higher score on the General Self-Efficacy Scale indicates a better outcome, as it signifies a stronger belief in one's ability to cope, persist, and successfully handle challenges.

  From enrollment, once every 2 months through study completion or participant withdrawal or death (average 2-5 years per participant)

Interventions

No intervention - Prospective cohort study OTHER

No intervention - Prospective cohort study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People living with MND in the UK

You may qualify if:

• People living with MND
• Living in the UK

Sponsors & Collaborators

• University of Sheffield: lead
• LifeArc: collaborator

Study Sites (1)

University of Sheffield

Sheffield, United Kingdom

RECRUITING

Related Publications (9)

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Rolland Y, Perrin A, Gardette V, Filhol N, Vellas B. Screening older people at risk of malnutrition or malnourished using the Simplified Nutritional Appetite Questionnaire (SNAQ): a comparison with the Mini-Nutritional Assessment (MNA) tool. J Am Med Dir Assoc. 2012 Jan;13(1):31-4. doi: 10.1016/j.jamda.2011.05.003. Epub 2011 Jun 23.

  PMID: 21700503 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Hobson E, Baird W, Bradburn M, Cooper C, Mawson S, Quinn A, Shaw PJ, Walsh T, McDermott CJ. Process evaluation and exploration of telehealth in motor neuron disease in a UK specialist centre. BMJ Open. 2019 Oct 22;9(10):e028526. doi: 10.1136/bmjopen-2018-028526.

  PMID: 31640994 BACKGROUND

• Whitehead B, O'Brien MR, Jack BA, Mitchell D. Experiences of dying, death and bereavement in motor neurone disease: a qualitative study. Palliat Med. 2012 Jun;26(4):368-78. doi: 10.1177/0269216311410900. Epub 2011 Jun 28.

  PMID: 21712334 BACKGROUND

• O'Brien MR, Whitehead B, Jack BA, Mitchell JD. The need for support services for family carers of people with motor neurone disease (MND): views of current and former family caregivers a qualitative study. Disabil Rehabil. 2012;34(3):247-56. doi: 10.3109/09638288.2011.605511.

  PMID: 22087569 BACKGROUND

• Hobson EV, Baird WO, Partridge R, Cooper CL, Mawson S, Quinn A, Shaw PJ, Walsh T, Wolstenholme D, Mcdermott CJ. The TiM system: developing a novel telehealth service to improve access to specialist care in motor neurone disease using user-centered design. Amyotroph Lateral Scler Frontotemporal Degener. 2018 Aug;19(5-6):351-361. doi: 10.1080/21678421.2018.1440408. Epub 2018 Feb 16.

  PMID: 29451026 BACKGROUND

• Hobson EV, Baird WO, Bradburn M, Cooper C, Mawson S, Quinn A, Shaw PJ, Walsh T, McDermott CJ. Using telehealth in motor neuron disease to increase access to specialist multidisciplinary care: a UK-based pilot and feasibility study. BMJ Open. 2019 Oct 22;9(10):e028525. doi: 10.1136/bmjopen-2018-028525.

  PMID: 31640993 BACKGROUND

• Opie-Martin S, Ossher L, Bredin A, Kulka A, Pearce N, Talbot K, Al-Chalabi A. Motor Neuron Disease Register for England, Wales and Northern Ireland-an analysis of incidence in England. Amyotroph Lateral Scler Frontotemporal Degener. 2021 Feb;22(1-2):86-93. doi: 10.1080/21678421.2020.1812661. Epub 2020 Sep 17.

  PMID: 32940088 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Chris McDermott, MBChB, FRCP, PhD

  University of Sheffield

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liam Knox, PhD

CONTACT

+44 114 222 2291; l.knox@sheffield.ac.uk

Chris McDermott, MBChB, FRCP, PhD

CONTACT

+44 114 222 2295; c.j.mcdermott@sheffield.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 50 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 20, 2025
• Study Start: December 14, 2024
• Primary Completion (Estimated): December 14, 2074
• Study Completion (Estimated): December 14, 2074
• Last Updated: August 20, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)