FibromyalgiaNCT05053464
A DCE to Understand Patients' Preferences for Alternative Models of Care
An observational study of Fibromyalgia, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
A pilot survey for a Discrete Choice Experience to understand the strength of patient's preferences for alternative models of care for fibromyalgia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Aug 2021to 8 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Respondents to a previous survey questionnaire who had told us they had a diagnosis of fibromyalgia
Who may be able to join
- Reporting a diagnosis of fibromyalgia in the DEHLTA survey
- Consenting to be contacted for future health survey research in the DEHLTA survey
Who cannot join
- Not reporting a diagnosis of fibromyalgia in the DEHLTA survey
- Not consenting to be contacted for future health survey research in the DEHLTA survey
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Medical subject headings
- Fibromyalgia
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preferences for treatment for fibromyalgia
This will be derived from the participants' answers to discrete choice questions
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start25 Aug 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053464
- Sponsor's protocol ID
- 2-041-21
- Status last verified
- May 2022
- First submitted
- 3 Sep 2021
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing New Models of Care for People With Fibromyalgia: Designing a DCE to Understand Patients' Preferences for Alternative Models of Care
- ClinicalTrials.gov ID
- NCT05053464
- Acronym / sponsor ID
- 2-041-21
- Conditions
- Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot survey for a Discrete Choice Experience to understand the strength of patient's preferences for alternative models of care for fibromyalgia.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Respondents to a previous survey questionnaire who had told us they had a diagnosis of fibromyalgia
Key inclusion criteria (2 listed)
- Reporting a diagnosis of fibromyalgia in the DEHLTA survey
- Consenting to be contacted for future health survey research in the DEHLTA survey
Key exclusion criteria (2 listed)
- Not reporting a diagnosis of fibromyalgia in the DEHLTA survey
- Not consenting to be contacted for future health survey research in the DEHLTA survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022; AzTrials last refreshed its copy on 1 Nov 2026.