A DCE to Understand Patients' Preferences for Alternative Models of Care

May 20, 2022 updated by: University of Aberdeen

Developing New Models of Care for People With Fibromyalgia: Designing a DCE to Understand Patients' Preferences for Alternative Models of Care

A pilot survey for a Discrete Choice Experience to understand the strength of patient's preferences for alternative models of care for fibromyalgia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

We will use the Discrete Choice Experiment (DCE) method to elicit preferences for alternative models of care for people with fibromyalgia. The DCE is a choice-based survey that quantifies preferences for attributes (or features) of goods, services or policy interventions. It assumes that any good or service (in this case models of care for fibromyalgia) can be described by its attributes and the measure (or 'levels') of these attributes. Each respondent faces a series of hypothetical scenarios (choice sets) composed of two or more alternatives. In each choice set, respondents are asked to choose their preferred scenario. The principle underlying a DCE is choices are made based on the features (or attributes) of different actions. Therefore, a DCE enables researchers to gain insight into the relative importance of each attribute, and the trade-offs between attributes.

This study is a survey of participants identified from a previous study about chronic widespread pain ("MAintaining MusculOskeleTal Health" - MAmMOTH). As part of the MAmMOTH study, a randomly selected sample of adults aged 25 years and over registered with participating general practices in Scotland were mailed a screening questionnaire. All individuals who returned the completed screening questionnaire and who met some criteria for fibromyalgia and consented to be contacted for future health survey research were approached for a further survey, the DEHLTA study. The DEHLTA survey questionnaire asked participants if they had ever received a diagnosis of fibromyalgia. From respondents to the DEHLTA study, individuals who said they had a diagnosis of fibromyalgia and who consented to be contacted for future studies will be eligible to participate in the current pilot study. We estimate this will be approximately 80 individuals.

Inclusion criteria are:

  • Reporting a diagnosis of fibromyalgia in the DEHLTA survey
  • Consenting to be contacted for future health survey research in the DEHLTA survey

Exclusion criteria are:

  • Not reporting a diagnosis of fibromyalgia in the DEHLTA survey
  • Not consenting to be contacted for future health survey research in the DEHLTA survey

Eligible individuals will receive a one-off paper questionnaire (including an invitation letter, a patient information sheet, and a prepaid, preaddressed envelope) and be invited to participate in the current study. A reminder letter will be mailed two weeks later. Mailings will be carried out by study staff at the University of Aberdeen.

We will analyse the feasibility of the model of data collection and quality of the questionnaire responses by estimating response rate, questionnaire completion times, item response and qualitative feedback on question items. In addition, we will assess frequencies and associations in choice responses to examine the strength of preferences relating to service provision in terms of the specified attributes (time to diagnosis, diagnosis provider, treatment type, waiting time, and type of on-going help and support). The data analysis conducted will inform the design of a larger study involving participants from a national patient organisation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Respondents to a previous survey questionnaire who had told us they had a diagnosis of fibromyalgia

Description

Inclusion Criteria:

  • Reporting a diagnosis of fibromyalgia in the DEHLTA survey
  • Consenting to be contacted for future health survey research in the DEHLTA survey

Exclusion Criteria:

  • Not reporting a diagnosis of fibromyalgia in the DEHLTA survey
  • Not consenting to be contacted for future health survey research in the DEHLTA survey

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Preferences for treatment for fibromyalgia
Time Frame: The outcome will be measured at a single timepoint, i.e. the time of completion of the survey questionnaire. The survey will be carried out during August and September 2021.
This will be derived from the participants' answers to discrete choice questions
The outcome will be measured at a single timepoint, i.e. the time of completion of the survey questionnaire. The survey will be carried out during August and September 2021.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aberdeen

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2-041-21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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