Investigating Musculoskeletal Health and Wellbeing

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 17, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

June 22, 2018

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Presence, severity and prevalence of frailty, as measured by response to the study questionnaire at annual intervals[ Time Frame: 5 years ]

Frailty will be classified using the 5-item FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight).

Presence and prevalence of pain[ Time Frame: 5 years ]

Pain distribution will be recorded in a pain manikin.

Presence and prevalence of disability[ Time Frame: 5 years ]

Disability will be determined using the five Fried Criteria modified for questionnaire delivery.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

1. Classification of phenotypic subgroups[ Time Frame: 5 years ]
Demographic characteristics will be recorded; age at baseline, sex, race, socioeconomic position (deprivation index, urban/rural indicators will be derived from postcode data), smoking habits, weight, height and alcohol consumption. Fracture risk will be assessed using a modified version of the FRAX instrument (substituting secondary osteoporosis for self-reported osteoporosis and without using data for bone mineral density measurements).
2. Classification of comorbid conditions[ Time Frame: 5 years ]
Co-morbidities will be assessed using the Charlson Comorbidity Index
3. Medication usage[ Time Frame: 5 years ]
Participants will self-report their current medications (prescribed and over the counter).
4. Identification of potential research participants[ Time Frame: 5 years ]
The Charlson Comorbidity Index
Prevalence of Comorbid conditions[ Time Frame: 5 years ]
the count of comorbidities
Classification of Rheumatic Comorbid conditions[ Time Frame: 5 years ]
Rheumatic Disease Comorbidity Index (RDCI).

Descriptive Information

Brief Title ^ICMJE

Investigating Musculoskeletal Health and Wellbeing

Official Title ^ICMJE

Investigating Musculoskeletal Health and Wellbeing: A Cohort Study

Brief Summary

Background The progression and associations of central and peripheral musculoskeletal pain, frailty, disability and fracture risks are not well known. This study aims to characterise the development and progression of different frailty, pain and disability phenotypes and their individual associations. Methods A prospective cohort of 10000 people aged > 18 will be recruited from general practice surgeries, secondary care and the general public. Data collection waves will be at baseline,and then annual follow-ups for up to five years. Data will be collected using a questionnaire asking about demographic characteristics, pain severity (0-10 scales), pain distribution (a pain Mannikin), pain quality (the McGill Pain Questionnaire), central pain (the CAP-Knee Scale), fracture risks (a modified version of the FRAX instrument), frailty (the Fried Criteria and the FRAIL scale) and disability (the FRAIL scale). Discussion Participant data will be analysed to determine phenotypic subgroups of frailty, pain and disability. Further to this, the progression of these characteristics and their influences upon health and wellbeing will be quantified.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Other: questionnaire
questionnaire

Study Arms

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

10000

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

April 30, 2023

Estimated Primary Completion Date

June 30, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Ability to give informed consent. Aged 18 and over Frailty score of ≥ 0.12 on the eFI Have or are at risk of developing musculoskeletal frailty, pain or disability Exclusion Criteria: - Inadequate understanding of verbal explanations or written information in English; Special communication needs; Receiving dialysis; Receiving home oxygen; Terminal cancer; Unstable angina or heart failure; Serious mental illness; Dementia.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Nottingham

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: David Walsh University of Nottingham

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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