The Oxford Pain, Activity and Lifestyle (OPAL) Cohort Study (OPAL)

April 28, 2021 updated by: University of Oxford
The OPAL study is about health outcomes in older adults. The investigators are surveying 4,000 adults across England to see how health and physical activity change over time. The information that is collected will help the investigators to understand how a person's health, including conditions such as back pain, affect their mobility as they age, and provide insight into improving the management of health in older adults.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The Oxford Pain, Activity and Lifestyle (OPAL) study is a large cohort study of community dwelling adults (n=4000) aged 65 years and over. This cohort data will allow the investigators to describe the prevalence, severity, course and prognosis a range of musculoskeletal problems in older people. The initial focus is to evaluate the impact of back pain on important health outcomes for older people (quality of life, mobility, falls and fractures). In order to do this, the investigators will study people with and without back pain at the inception of the cohort. The OPAL cohort will be followed for 5 years in the first instance and the investigators will study a range of factors hypothesised to moderate and mediate the effects of back and other musculoskeletal pain for example, co-morbidities.

The OPAL cohort will be sampled from older people registered with primary care practices.

The investigators aim to develop a prognostic tool using the cohort data that will help older people, GPs and other health professionals identify when LBP is a risk factor for disability, functional limitation and loss of mobility, and when LBP should be prioritised as a treatment target.

Study Type

Observational

Enrollment (Actual)

5409

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LD
        • University of Oxford, Botnar Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants in the OPAL cohort study will be community dwelling adults, aged 65 years and over, registered with a primary care practice

Description

Inclusion Criteria:

  • Registered with a primary care practice.
  • 65 years and over.

Exclusion Criteria:

  • Living in a residential care or nursing home.
  • Has a terminal condition with a life expectancy of less than 6 months.
  • Any substantial health or social concern that, in the opinion of the patient's GP, would place the patient at increased risk or inability to participate including known inability to provide informed consent e.g. Dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Life-Space assessment
Time Frame: 5 years
Life-Space Assessment measures mobility in terms of the spatial extent of a person's life. The purpose of the Life-Space Assessment is to determine a person's usual pattern of mobility during the month preceding the assessment. Life-space is defined based upon the distance a person routinely travels to perform activities over this time frame. This includes determining how far and how often the person leaves his or her place of residence and the degree of independence the person has.
5 years
Self-reported falls
Time Frame: 5 years
The investigators will use the definitions of the Prevention of Falls Network Europe consensus on core outcomes which provides standard definitions of falls.
5 years
EQ-5D-5L
Time Frame: 5 years
Disability and health-related quality of life is measured by the EQ-5D-5L
5 years
Tilburg Frailty Indicator
Time Frame: 5 years
5 years
Health Resource Use
Time Frame: 5 years
Health resource use will be captured through routine health service data collection systems (Hospital Episode Statistics: inpatient, accident and emergency and diagnostic imaging datasets).
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Sarah Lamb, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2016

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS ID: 196643

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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