Vitger, Tobias http://orcid.org/0000-0001-7492-5493
Austin, Stephen F.
Petersen, Lone
Tønder, Esben S.
Nordentoft, Merete
Korsbek, Lisa
Funding for this research was provided by:
TrygFonden (115441)
Article History
Received: 2 January 2019
Accepted: 6 May 2019
First Online: 17 June 2019
Ethics approval and consent to participate
: There are no known side effects, risks, complications or disadvantages of participating in the Momentum project. The trial has been approved by the Regional Ethics Committee in The Capital Region of Denmark under file number H-17025550 and the Danish Data Protection Agency under file number 2012-58-0004. The trial is registered at ExternalRef removed as ‘trial reference’ under the identifier: NCT03554655. The law on handling of personal data will be respected. All positive, neutral and negative findings of the trial will be published according to the CONSORT-eHealth guidelines. All outcome data are stored in REDCap at a secure server at the Capital Region, Copenhagen, Denmark.All potential participants will receive information in both written and verbal form and participants may bring a friend or relative to the meetings with the researcher. The information will be delivered and explained in a non-technical and neutral language. Patients will be offered time for consideration. Participants are informed that participation is voluntary and that consent can be withdrawn at any time during the trial without this having any consequences for future treatment possibilities. All participating patients sign a consent form and get a copy of this and their rights as a participant in a clinical trial. Participants do not receive any economic compensation for participating in the Momentum trial.
: Not applicable.
: The authors declare that they have no competing interests.
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