MedDataX Logo

Citizen Science: The People's Trial: A Randomised Controlled Trial

NCT ID: NCT04185818

Last Updated: 2020-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2020-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The People's trial is an online pragmatic, randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The People's Trial seeks to help enhance the public's understanding of randomised trials by facilitating the involvement of the public in the trial research process. The public have, through an online format, guided the development and design of The People's Trial randomised controlled trial. The People's trial is a parallel, online randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.

Members of the public will be recruited through online platforms. Informed consent will be obtained from all participants prior to trial registration. Consent forms will be provided online prior to registration for The People's Trial. Participants will be required to acknowledge that they have read the consent form and give consent to proceed with trail registration.

Participants will be randomly allocated into one of two groups:

Group 1: Reading a book in bed

Group 2: Not reading a book in bed

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sleep, book, read, bed

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The People's Trial is an online pragmatic, randomised controlled trial.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reading group

Participants will:

1. Read a book for 15 to 30 mins
2. Read immediately before trying to go to sleep.

Group Type EXPERIMENTAL

Reading a book

Intervention Type OTHER

Participants requested to specify usual genre of book they read.

1. Fiction
2. Non-Fiction
3. Other
4. Don't usually read a book in bed

Control Group

Participants will:

1\. Not read a book

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reading a book

Participants requested to specify usual genre of book they read.

1. Fiction
2. Non-Fiction
3. Other
4. Don't usually read a book in bed

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ≥ 18 years of age on enrollment;
* English speaking;
* ability to read;

Exclusion Criteria

* Members of the public who are unwilling or unable to give informed consent.
* Unable to go to bed and wake up at the same time as normal for the study duration.
* Unable to sleep in their own bed, in their own home for the study duration
* Unable to not eat food or drink caffeinated drinks within 1 hour of bed for the study duration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Health Research Board, Ireland

OTHER

Sponsor Role collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Declan Devane

Scientific Director, HRB-Trials Methodology Research Network

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Declan Devane, Professor

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National University of Ireland Galway

Galway, Co. Galway, Ireland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland

References

Explore related publications, articles, or registry entries linked to this study.

Finucane E, O'Brien A, Treweek S, Newell J, Das K, Chapman S, Wicks P, Galvin S, Healy P, Biesty L, Gillies K, Noel-Storr A, Gardner H, O'Reilly MF, Devane D. The People's Trial: supporting the public's understanding of randomised trials. Trials. 2022 Mar 9;23(1):205. doi: 10.1186/s13063-021-05984-1.

Reference Type DERIVED
PMID: 35264220 (View on PubMed)

Finucane E, O'Brien A, Treweek S, Newell J, Das K, Chapman S, Wicks P, Galvin S, Healy P, Biesty L, Gillies K, Noel-Storr A, Gardner H, O'Reilly MF, Devane D. Does reading a book in bed make a difference to sleep in comparison to not reading a book in bed? The People's Trial-an online, pragmatic, randomised trial. Trials. 2021 Dec 4;22(1):873. doi: 10.1186/s13063-021-05831-3.

Reference Type DERIVED
PMID: 34996514 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HRB.ThePeople'sTrial

Identifier Type: -

Identifier Source: org_study_id