Parkinson’s disease (PD), multiple sclerosis (MS), chronic obstructive pulmonary disease (COPD), proximal femoral fracture (PFF) Other Parkinson disease, multiple sclerosis, other chronic obstructive pulmonary disease, fracture of femur
Conditions
Interventions
Participants will attend a baseline visit and four follow up visits every 6 months (study length is 24 months). Each visit will involve the completion of questionnaires and assessments including:
1. D
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/07/2021: All participants: 1. Adults aged 18 years or over 2. Able to walk 4 meters independently with or without walking aids 3. Anticipated availability for repeated study visits over 24 months 4. Ability to consent and comply with any study-specific procedures. 5. Willingness to wear the McRobert’s body sensor (DynaPort MoveMonitor) 6. Able to read and write in first language in the respective country PD Cohort: 1. Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society 2. Hoehn & Yahr stage I-III. MS Cohort: 1. A diagnosis of MS based on the revised McDonald’s criteria 2. EDSS score of 3.0 - 6.5 3. Clinical evidence of disability worsening over the previous two years COPD Cohort: 1. Diagnosis of COPD (post-bronchodilator forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) ratio <0.70 2, Clinical stability, defined as at least 4 weeks after the onset of the last exacerbation 3. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) PFF Cohort: 1. Surgical treatment (fixation or arthroplasty) for a low-energy fracture of the proximal femur (ICD-10 diagnosis S72.0, S72.1, S72.2) as diagnosed on X-rays of the hip and pelvis. Between 3 days and 52 weeks post-surgery 2. Aged 45 years or older _____ Previous inclusion criteria: All participants: 1. Adults aged 18 or over 2. Able to walk 4 meters independently with or without walking aids 3. Anticipated availability for repeated study visits over 24 months 4. Ability to consent and comply with any study specific procedures. 5. Willingness to wear the McRobert’s body sensor (DynaPort MoveMonitor) 6. Able to read and write in first language in the respective country PD Cohort: 1. Patients with the clinical diagnosis of PD according to the recent criteria of the Movement Disorder Society 2. Hoehn & Yahr stage I-III. MS Cohort: 1. A diagnosis of MS based on the revised McDonald’s criteria 2. EDSS score of 3.0-6.5. 3. Evidence of confirmed disability progression within the 12 months prior to screening (defined by a 6-month confirmed EDSS increase of 1.0-point for participants if the EDSS score was 3.0 to 5.5 and a 0.5-point if the EDSS score was 6.0 to 6.5). COPD Cohort: 1. Diagnosis of COPD (post-bronchodilator forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) ratio <0.70 2, Clinical stability, defined as at least 4 weeks after the onset of the last exacerbation 3. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) PFF Cohort: 1. Surgical treatment (fixation or arthroplasty) for a low-energy fracture of the proximal femur (ICD-10 diagnosis S72.0, S72.1, S72.2) as diagnosed on X-rays of the hip and pelvis. Between 3 days and 52 weeks post-surgery 2. Aged 45 years or older (added 14/04/2021)
Exclusion criteria
Exclusion criteria: All participants: 1. Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse. PD Cohort: 1. History consistent with Dementia with Lewy Bodies (DLB), atypical parkinsonian syndromes (including multiple system atrophy or progressive supranuclear palsy, diagnosed according to accepted criteria) 2. Repeated strokes or stepwise progression of symptoms, leading to a diagnosis of ‘vascular parkinsonism’ 3. Drug-induced Parkinsonism MS Cohort: 1. Clinical relapse within 30 days prior to screening and baseline. COPD Cohort: 1. Having undergone major lung surgery (e.g. lung transplant) 2. Current diagnosis of lung cancer 3. Primary respiratory diseases other than COPD 4. Substantial limitations in mobility due to factors other than COPD 5. Lung volume reduction within 6 months before inclusion PFF Cohort: 1. Not able to walk before treatment of hip fracture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/10/2022: Global primary outcome: Change in the functional component score of the Late-Life Functional Disability Index (LLFDI) during 12-month follow-up. There are also disease-specific primary outcomes for each cohort: 1. PD Cohort: Fall frequency during first 12 months follow-up, collected via face-to-face interview, participant-completed falls diaries and hospital records at baseline, 6 and 12 months. 2. MS Cohort: Fall frequency during first 12 months follow-up, collected via face-to-face interview, participant-completed falls diaries and hospital records at baseline, 6 and 12 months. 3. COPD Cohort: Occurrence of moderate-to-severe COPD exacerbations during the first 12 months of follow-up, collected via face-to-face interview, participant-completed falls diaries and hospital records at baseline, 6 and 12 months. 4. PFF Cohort: Admission to a care home assessed from patient records at 6 months follow-up. _____ Previous primary outcome measure: Global primary outcome: Change in the functional component score of the Late-Life Functional Disability Index (LLFDI) during 24-month follow-up, measured at baseline, 6, 12, 18 and 24 months There are also disease-specific primary outcomes for each cohort: 1. PD Cohort: Fall frequency during 24 months follow-up, collected via face-to-face interview, participant-completed falls diaries and hospital records at baseline, 6, 12, 18 and 24 months 2. MS Cohort: Fall frequency during 24 months follow-up, collected via face-to-face interview, participant-completed falls diaries and hospital records at baseline, 6, 12, 18 and 24 months 3. COPD Cohort: Occurrence of moderate-to-severe COPD exacerbations during the first 12 months of follow-up, collected via face-to-face interview, participant-completed falls diaries and hospital records at baseline, 6 and 12 months 4. PFF Cohort: Admission to a care home assessed from patient records at 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/10/2022: 1. Assess predictive capacity of DMOs over 12 months. 2. Assess construct validity of DMOs over 12 months. 3. Assess ability of DMOs to detect change over 12 months. 4. Estimate the Minimum Important Difference of DMOs to measure change over 12 months. 5. Describe real-world walking behaviour with DMO’s. _____ Previous secondary outcome measures: There are no secondary outcome measures | — |
Countries
Belgium, England, France, Germany, Greece, Israel, Italy, Norway, Spain, Switzerland, United Kingdom
Outcome results
None listed