Condition category
Pregnancy and Childbirth
Date applied
07/03/2019
Date assigned
15/04/2019
Last edited
20/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Decision-making tools represent a paradigm shift in the relationship between the clinician and the user/patient. They offer the advantage of compromising the patient, especially in those decisions that are sensitive to their preferences and values when there is more than one reasonable health option, they reduce the stressful burden that uncertainty can cause due to lack of information, and increase the proportion of people active in the management and management of their health. Allowing the user to freely access them from any digital device, not necessarily located in a clinic, at any time, facilitates personal reflection in making the decision that best suits their preferences, needs and state of health. However, there is a lack of research studies that demonstrate that online digital decision making tools in contraception provide advantages in relation to pre-technological care/attention. The aim of this study is to assess the effectiveness of a decision-making tool in contraception (SHARECONTRACEPT: http://decisionscompartides.gencat.cat/ca/decidir-sobre/anticoncepcio_hormonal/).

Who can participate?
Women aged 16 (updated 06/06/2019, previously: 18) to 49 who attend consultations at the clinical contraceptive counseling units participating in the study

What does the study involve?
The health professionals participating in each unit are randomly allocated to one of two groups. Clinicians allocated to the experimental group perform contraceptive counseling assisted by SHARECONTRACEPT, and those of the control group follow the usual procedure of their clinical unit. The selected users are followed up for one year. Data is collected through questionnaires, a logbook of incidents and validated instruments for measuring decisional conflict and adherence to treatment.

What are the possible benefits and risks of participating?
The results obtained from this study will help us to establish a Decision Support Tool in hormonal contraception, if it is shown that it has clear benefits, in giving better care to women who come for contraception counseling. Participation in this study does not pose any risk, but there may not be any health benefits from participating in this study.

Where is the study run from?
Clinical contraceptive counseling units of six autonomous regions in Spain

When is the study starting and how long is it expected to run for?
January 2019 to December 2021

Who is funding the study?
Instituto de Salud Carlos III (Ministry of Science, Innovation and Universities co-funded by the European Fund for International Development of the European Union)

Who is the main contact?
1. Dr Maria Inmaculada de Molina Fernandez
inmaculada.demolina@urv.cat
2. Dr Laia Raigal-Aran
laia.raigal@urv.cat

Trial website

Contact information

Type

Scientific

Primary contact

Dr Maria Inmaculada de Molina-Férnandez

ORCID ID

http://orcid.org/0000-0002-1429-4455

Contact details

Av/Catalunya
nº35
Tarragona
43002
Spain
+34 (0)625454741; +34 (0)977293402
inmaculada.demolina@urv.cat

Type

Scientific

Additional contact

Dr Laia Raigal-Aran

ORCID ID

http://orcid.org/0000-0003-3308-0572

Contact details

Av/Catalunya
nº35
Tarragona
43002
Spain
+34 (0)977299402
laia.raigal@urv.cat

Type

Scientific

Additional contact

Ms Dolores Creus-Pujol

ORCID ID

Contact details

Institut Català de la Salut.
Gran Via de les Corts Catalanes
587
589
Barcelona
08004
Spain
(+34) 627480724
dcreus.lleida.ics@gencat.cat

Type

Scientific

Additional contact

Dr Miriam De la Flor-López

ORCID ID

http://orcid.org/0000-0002-6232-7266

Contact details

Hospital Universitari de Tarragona Joan XXIII
Tarragona
43005
Spain
(+34) 977295800
mdelaflor.hj23.ics@gencat.cat

Type

Scientific

Additional contact

Dr José Ramón Escuriet-Peiro

ORCID ID

http://orcid.org/0000-0002-7277-3331

Contact details

Catalan Health Service
Government of Catalonia
Faculty of Health Sciences Blanquerna-URLL
Barcelona
-
Spain
(+34) 933156966
rescuriet@gencat.cat

Type

Scientific

Additional contact

Dr Isabel Font-Jimenez

ORCID ID

Contact details

Universitat Rovira i Virgili
Tarragona
-
Spain
(+34) 977299414
isabel.font@urv.cat

Type

Scientific

Additional contact

Ms Gemma March-Jardí

ORCID ID

Contact details

Institut Català de la Salut.
Gran Via de les Corts Catalanes
587
589
Barcelona
08004
Spain
(+34) 977920400
gmarch.tgn.ics@gencat.cat

Type

Scientific

Additional contact

Dr Cristina Martinez-Bueno

ORCID ID

http://orcid.org/0000-0001-5437-812X

Contact details

Institut Català de la Salut
Barcelona
-
Spain
(+34) 934824391
cmartinezbu@gencat.cat

Type

Scientific

Additional contact

Ms Maria Dolores Martinez-Romero

ORCID ID

http://orcid.org/0000-0003-2797-4166

Contact details

Dirección general de asistencia sanitaria del SERGAS
Santiago de Compostela
-
Spain
(+34) 881548640
maria.dolores.martinez.romero@sergas.es

Type

Scientific

Additional contact

Dr Lucia Martinez-Villarejo

ORCID ID

Contact details

Midwifery training unit
Madrid
-
Spain
(+34) 917277470
luciamartinezvillarejo@gmail.com

Type

Scientific

Additional contact

Ms Montserrat Moharra-Frances

ORCID ID

Contact details

Agència de Qualitat i Avaluació Sanitaries
Generalitat de Catalunya
Barcelona
08005
Spain
(+34) 935513905
mmoharra@gencat.cat

Type

Scientific

Additional contact

Prof Jose Cruz Quilez-Conde

ORCID ID

Contact details

Hospital Universitario de Basurto
Bilbao
-
Spain
(+34) 944006000
josecruz.quilezconde@osakidetza.eus

Type

Scientific

Additional contact

Ms Anna Rodriguez-Martinez

ORCID ID

Contact details

Institut Català de Salut Bacelona
Generalitat de Catalunya
Barcelona
-
Spain
(+34) 936932732
arodriguezma.mb.ics@gencat.cat

Type

Scientific

Additional contact

Dr Lourdes Rubio-Rico

ORCID ID

Contact details

Universitat Rovira i Virgili
Tarragona
-
Spain
(+34) 977299416
lourdes.rubio@urv.cat

Type

Scientific

Additional contact

Ms Demetria Patricio-Peña

ORCID ID

Contact details

Institut Català de la Salut
Barcelona
-
Spain
(+34) 675782222
dpatricio.tgn.ics@gencat.cat

Type

Scientific

Additional contact

Dr Francesc Valls-Fonayet

ORCID ID

Contact details

Universitat Rovira i Virgili
Tarragona
-
Spain
(+34) 977558350
francesc.valls@urv.cat

Type

Scientific

Additional contact

Dr Federico Villagrasa-Rocher

ORCID ID

Contact details

Centro de Salud Sexual y Reproductiva
Departamento de Alcoi. Conselleria de Sanitat.
Generalitat Valenciana
Valencia
-
Spain
(+34) 966527766
villagrasa_fed@gva.es

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PI18/00915

Study information

Scientific title

SHARECONTRACEPT, a digital decision-making-tool. Does it improve adherence to the chosen contraceptive method?

Acronym

SHARECONTRACEPT

Study hypothesis

This study will find out the effectiveness of a shared decision-making tool in contraception in health settings in Spain.

The study aims are to evaluate the effectiveness of shared decision-making tool on hormonal contraception (SHARECONTRACEPT) measured by:
1. The improvement of counseling on hormonal contraception at the clinic consultation
2. The increase of clinical healthcare professionals knowledge on contraception
3. The improvement of adherence to contraception treatment selected
4. The decreasing unwanted pregnancies and voluntary interruption of pregnancy

Ethics approval

Ethics Committees of Clinical Research:
1. Comité Ético de investigación del Instituto Pere Virgili, Institut d’Investigació Danitària Pere Virgili (IISPV), Centre d'R+D+I en Nutrició i Salut, Avda. de la Universitat, 1 - 2a planta, 43204 Reus (Tarragona), Spain, Tel: +34 (0)977 75 93 94, ref: 186/2018
2. Comité Ético Investigación Clínica del IDIAP Jordi Gol, Fundació Institut Universitari per a la recerca d’Atenció Primària de Salut Jordi Gol i Guirina (IDAPJGol), Gran Via Corts Catalanes, 587, 08007 (Barcelona), Spain, Tel: +34 (0)93 482 41 24, Email: idap@idiapjgol.org, 28/11/2018, ref: PI18/208

Study design

Longitudinal and prospective community clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Contraception

Intervention

This study will include an intervention group and a control group and data will be collected during a year in 6 autonomous regions in Spain. The health professionals participating in each unit will be randomly assigned by simple randomization to one of two groups. Clinicians assigned to the experimental group will perform contraceptive counseling assisted by SHARECONTRACEPT, and those of the control group will follow the usual protocol of their clinical unit.

It is planned to study 1,708 health users, recruited from women who attend the consultations of the units participating in the study. The selected users will be followed for one year. The data will be collected through ad-hoc questionnaires and validated instruments for measuring decisional conflict and adherence to treatment. A set of bivariate and multivariable descriptive analyses, besides a regression study analysis, will be carried out.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Adherence to treatment: compliance with dosage and method of administration and persistence in the duration of prescribed treatment, evaluated through a structured interview ad-hoc including questions about a) the compliance with the contraceptive method chosen in the clinical consultation, b) information about the usage of this method and c) unwanted pregnancy incidences. Assessed by a phone call at 1 month, 6 months and 1 year.

Secondary outcome measures

1. Sociodemographic characteristics of the patient: age, educational level, occupation, marital status/couple, assessed at a structured interview ad-hoc at the first contact in the clinical consultation
2. Medical history: smoking habits, HBP, uterine malformations, diabetes, assessed at a structured interview ad-hoc at the first contact in the clinical consultation
3. Obstetric and gynecological antecedents: menstrual formula, menarche, term or premature pregnancies, ectopic pregnancies, spontaneous abortions, IVE, gynecological reviews according to the guidelines of each community, active sexually transmitted diseases, living children, desire to have children, assessed at a structured interview ad-hoc at the first contact in the clinical consultation
4. Contraceptive method: contraceptive method contemplated by the patient before counseling, prejudices against other contraceptives, experiences with other methods, possible beneficial non-contraceptive effects, importance of the cost in her choice, women's behavior with respect to compliance (Morisky-Green's adherence to treatment), finally chosen contraceptive, incidents with the chosen method, management of the incidences, decisional conflict of the woman before the choice of the contraceptive method (O'Connor Scale), assessed at a structured interview ad-hoc at the first contact in the clinical consultation
5. Professional: satisfaction of the advisor or clinician with the use of the Digital HATD (Likert scale), acquired knowledge (ad-hoc knowledge test) assessed after the first year recruiting women for the study

Overall trial start date

01/01/2019

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current participant inclusion criteria as of 28/05/2019:
1. Women aged 16 or older
2. Women aged 49 years or younger
3. Have primary studies and are proficient in Spanish and/or Catalan
4. Have access to the internet
5. Agree to voluntarily participate in the study

Previous participant inclusion criteria:
1. Women aged 18 or older
2. Women aged 49 years or younger
3. Have primary studies and are proficient in Spanish and/or Catalan
4. Have access to the internet
5. Agree to voluntarily participate in the study

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1708

Participant exclusion criteria

1. Women aged 17 years or younger
2. Women aged 50 or older
3. Women who wish to have children before one year from the date of the consultation
4. Don't have access to internet
5. Don't understand Catalan and/or Spanish

Recruitment start date

01/07/2019

Recruitment end date

30/06/2020

Locations

Countries of recruitment

Spain

Trial participating centre

Consulta Anticoncepción Hospital Clínico Universitario Area 2 y 3
Zaragoza (Aragón)
50009
Spain

Trial participating centre

Consulta Atención Primaria CEM Casetas
50620
Spain

Trial participating centre

Zona Salud Fuentes de Ebro, Belchite y Azuara
Zaragoza (Aragón)
50740
Spain

Trial participating centre

Centro Salud Picarral
Zaragoza (Aragón)
50015
Spain

Trial participating centre

Centro de Salud Torrero-La Paz
Zaragoza (Aragón)
50007
Spain

Trial participating centre

Centro de Salud San Pablo
Zaragoza (Aragón)
50003
Spain

Trial participating centre

Centro de Salud Luna
Zaragoza (Aragón)
50610
Spain

Trial participating centre

Centro de Salud Zuera
Zaragoza (Aragón)
50800
Spain

Trial participating centre

ASSIR Esquerraa - CAP Manso. Institut Català de la Salut
Barcelona (Catalunya)
08015
Spain

Trial participating centre

ASSIR Esquerra - CAP Numància. Institut Català de la Salut
Barcelona
08015
Spain

Trial participating centre

ASSIR Dreta - Roger de Flor. Institut Català de la Salut
Barcelona (Catalunya)
08013
Spain

Trial participating centre

ASSIR Dreta - Pare Claret. Institut Català de la Salut
Barcelona (Catalunya)
08037
Spain

Trial participating centre

ASSIR Dreta - La Sagrera. Institut Català de la Salut
Barcelona (Catalunya)
08027
Spain

Trial participating centre

ASSIR Muntanya - Ciutat Meridiana. Institut Català de la Salut
Barcelona (Catalunya)
08033
Spain

Trial participating centre

ASSIR Muntanya .Chafarines. Institut Català de la Salut
Barcelona (Catalunya)
08033
Spain

Trial participating centre

ASSIR Muntanya - Rio de Janeiro. Institut Català de la Salut
Barcelona (Catalunya)
08016
Spain

Trial participating centre

ASSIR Muntanya - Guineueta. Institut Català de la Salut
Barcelona (Catalunya)
08042
Spain

Trial participating centre

ASSIR Muntanya - Roquetes. Institut Català de la Salut
Barcelona (Catalunya)
08042
Spain

Trial participating centre

ASSIR Muntanya - Horta. Institut Català de la Salut
Barcelona (Catalunya)
08032
Spain

Trial participating centre

ASSIR Sabadell - CAP St Fèlix. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08204
Spain

Trial participating centre

ASSIR Sabadell - CAP Creu Alta. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08280
Spain

Trial participating centre

ASSIR Sabadell - CAP Centre. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08201
Spain

Trial participating centre

ASSIR Sabadell - CAP Sant Quirze. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08192
Spain

Trial participating centre

ASSIR Sabadell - CAP N'Oriac. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08207
Spain

Trial participating centre

ASSIR Sabadell - CAP Castellar. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08211
Spain

Trial participating centre

ASSIR Mataró - CAP Ronda Prim. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08302
Spain

Trial participating centre

ASSIR Cerdanyola-Ripollet - CAP Cerdanyola-Ripollet. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08291
Spain

Trial participating centre

ASSIR Santa Coloma de Gramanet - CAP Santa Coloma de Gramanet. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08922
Spain

Trial participating centre

ASSIR Sabadell - CAP Can Rull. Institut Català de la Salut
Barcelona Metropolitana Nord (Catalunya)
08206
Spain

Trial participating centre

ASSIR Lleida - CAP Pla d'Urgell. Institut Català de la Salut
Lleida (Catalunya)
25230
Spain

Trial participating centre

ASSIR Lleida - CAP Almacelles. Institut Català de la Salut
Lleida (Catalunya)
25100
Spain

Trial participating centre

ASSIR Lleida - CAP Almenar. Institut Català de la Salut
Lleida (Catalunya)
25126
Spain

Trial participating centre

ASSIR Lleida - CAP La Bordeta. Institut Català de la Salut
Lleida (Catalunya)
25001
Spain

Trial participating centre

ASSIR Lleida - CAP Tàrrega. Institut Català de la Salut
Lleida (Catalunya)
25300
Spain

Trial participating centre

ASSIR Lleida - CAP Alcarràs. Institut Català de la Salut
Lleida (Catalunya)
25180
Spain

Trial participating centre

ASSIR Lleida - CAP Cappont. Institut Català de la Salut
Lleida (Catalunya)
25001
Spain

Trial participating centre

ASSIR Lleida - CAP Eixample . Institut Català de la Salut
Lleida (Catalunya)
25006
Spain

Trial participating centre

ASSIR Lleida - CAP Onze de Setembre . Institut Català de la Salut
Lleida (Catalunya)
25005
Spain

Trial participating centre

ASSIR Lleida - CAP Agramunt . Institut Català de la Salut
Lleida (Catalunya)
25310
Spain

Trial participating centre

ASSIR Lleida - CAP Artesa . Institut Català de la Salut
Lleida (Catalunya)
25730
Spain

Trial participating centre

ASSIR Lleida - CAP Ponts . Institut Català de la Salut
Lleida (Catalunya)
25740
Spain

Trial participating centre

ASSIR Lleida - CAP Apicat . Institut Català de la Salut
Lleida (Catalunya)
25110
Spain

Trial participating centre

ASSIR Lleida - CAP Torrefarrera . Institut Català de la Salut
Lleida (Catalunya)
25123
Spain

Trial participating centre

ASSIR Lleida - CAP Primer de Maig . Institut Català de la Salut
Lleida (Catalunya)
25003
Spain

Trial participating centre

ASSIR Lleida - CAP Cervera . Institut Català de la Salut
Lleida (Catalunya)
25200
Spain

Trial participating centre

ASSIR Lleida - CAP Balafia . Institut Català de la Salut
Lleida (Catalunya)
25005
Spain

Trial participating centre

ASSIR Lleida - CAP Les Borges Blanques . Institut Català de la Salut
Lleida (Catalunya)
25400
Spain

Trial participating centre

ASSIR Lleida - CAP 11 de setembre . Institut Català de la Salut
Lleida (Catalunya)
25005
Spain

Trial participating centre

ASSIR Tarragona-Valls - CAP Jaume I . Institut Català de la Salut
Tarragona (Catalunya)
43005
Spain

Trial participating centre

ASSIR Tarragona-Valls - CAP Sant Pere i Sant Pau . Institut Català de la Salut
Tarragona (Catalunya)
43007
Spain

Trial participating centre

ASSIR Tarragona-Valls - CAP Torreforta . Institut Català de la Salut
Tarragona (Catalunya)
43006
Spain

Trial participating centre

ASSIR Tarragona-Valls - CAP Bonavista . Institut Català de la Salut
Tarragona (Catalunya)
43100
Spain

Trial participating centre

ASSIR Tarragona-Valls - CAP Salou . Institut Català de la Salut
Tarragona (Catalunya)
43840
Spain

Trial participating centre

ASSIR Reus-Altebrat - CAP Sant Pere . Institut Català de la Salut
Tarragona (Catalunya)
43202
Spain

Trial participating centre

Hospital Joan XXIII . Institut Català de la Salut
Tarragona (Catalunya)
43005
Spain

Trial participating centre

ASSIR Tarragona-Valls - CAP Valls . Institut Català de la Salut
Tarragona (Catalunya)
43800
Spain

Trial participating centre

Centre de Salud Sexual y Reproductiva de Alcoi
Alcoi-Alicant (Comunitat de València)
203801
Spain

Trial participating centre

Instituto Gallego de Ginecología. HM La Rosaleda (Santiago de Compostela)
Santiago de Compostela (Galicia)
15701
Spain

Trial participating centre

Centro de Salud Porto do Son y Lousame (EOXI Santiago)
Acoruña (Galicia)
15970
Spain

Trial participating centre

Centro de Salud O Pino y Touro (EOXI Santiago)
Acoruña (Galicia)
15821
Spain

Trial participating centre

Centro de Salud Ordes (EOXI Santiago)
Acoruña (Galicia)
15680
Spain

Trial participating centre

Centro de Salud Melide (EOXI Santiago)
Acoruña (Galicia)
15800
Spain

Trial participating centre

Centro de Salud Portazgo Culleredo (EOXI A CORUÑA)
Acoruña (Galicia)
15174
Spain

Trial participating centre

Centro de Salud Narón (EOXI Ferrol)
Acoruña (Galicia)
15570
Spain

Trial participating centre

Centro de Salud Neda (EOXI Ferrol)
Acoruña (Galicia)
15510
Spain

Trial participating centre

Centro de Salud San Roque (EOXI Lugo, Cervo e Monforte de Lemos)
Lugo (Galicia)
27002
Spain

Trial participating centre

CS Ribadavia (EOXI Ourense, Verín e O Barco de Valdeorras)
Ourense (Galicia)
32400
Spain

Trial participating centre

COF Novoa Santos (EOXI Ourense, Verín e O Barco de Valdeorras)
Ourense (Galicia)
32003
Spain

Trial participating centre

Centro de Salud Monteporreiro (EOXI Pontevedra e O Salnés)
Pontevedra (Galicia)
36162
Spain

Trial participating centre

Centro de Salud Ponteareas (EOXI Vigo)
Pontevedra (Galicia)
36860
Spain

Trial participating centre

Centro de Salud Legazpi (DA Norte)
Madrid (Madrid)
28045
Spain

Trial participating centre

Centro de Salud Los Cármenes (DA Centro)
Madrid (Madrid)
28047
Spain

Trial participating centre

CS General Fanjul (DA Centro)
Madrid (Madrid)
28044
Spain

Trial participating centre

CS Embajadores (DA Norte)
Madrid (Madrid
28012
Spain

Trial participating centre

Centro de Salud Juan de la Cierva (DA Sur)
Madrid (Madrid)
28901
Spain

Trial participating centre

Consulta planificación, CARPA, Logroño, La Rioja
La Rioja-Logroño (Pais Vasco)
26004
Spain

Trial participating centre

Hospital Donostia (San Sebastián – Gipuzkoa)
San Sebastián-Guipuzkoa (Pais Vasco)
20014
Spain

Trial participating centre

Hospital Alto Deba (Arrasate-Mondragón).- Guipuzcoa
Arrasate-Guipuzkoa (Pais Vasco)
20500
Spain

Trial participating centre

Hospital de Mendaro, (Mendaro) (Gipuzkoa)
Mendaro-Guipuzkoa (Pais Vasco)
20850
Spain

Trial participating centre

Clínica Euskalduna (Bilbao - Bizkaia)
Bilbao - Bizkaia (Pais Vasco)
48008
Spain

Trial participating centre

Clínica Ginecológica Bilbao (Bilbao – Bizkaia)
Bilbao (Pais Vasco)
48006
Spain

Trial participating centre

Hospital Universitario de Basurto (Bilbao - Bizkaia)
Bilbao (Pais Vasco)
48013
Spain

Trial participating centre

Centro de Salud Olárizu. Vitoria (Araba)
Vitoria (Pais Vasco)
01006
Spain

Trial participating centre

Centro de Salud Lutxana OSI BDO-Sestao Bizkaia
Bizkaia (Pais Vasco)
48903
Spain

Trial participating centre

Centro de Salud La Paz ,Cruces (Barakaldo – Bizkaia)
Bizkaia (Pais Vasco)
48903
Spain

Trial participating centre

Centro de Salud Markonzaga, Sestao (Bizkaia)
Bizkaia (Pais Vasco)
48903
Spain

Sponsor information

Organisation

Universitat Rovira i Vigili

Sponsor details

Department and Faculty of Nursing
Av/Catalunya
35
Tarragona
43002
Spain
+34 (0)977299402 - 625454741
inmaculada.demolina@urv.cat

Sponsor type

University/education

Website

http://www.fi.urv.cat

Funders

Funder type

Research organisation

Funder name

Instituto de Salud Carlos III (Ministry of Science, Innovation and Universities co-funded by the European Fund for International Development of the European Union)

Alternative name(s)

Institute of Health Carlos III, Carlos III Health Institute, ISCIII

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Spain

Results and Publications

Publication and dissemination plan

1. A general report of all results will be made (end of 2021)
2. Congress contributions (poster and communications)
3. At least one or two paper will be submitted to an international journal during 2021 (preferably Q1 Journal)

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Maria Inmaculada de Molina (inmaculada.demolina@urv.cat). Data will be available at the end of the study (around 2021).

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/06/2019: The scientific contact Dr Sira Repolles-Lasheras was removed. 19/06/2019: The address of the scientific contact Dr Cristina Martinez-Bueno was corrected and ORCID ID was added. 12/06/2019: The ORCID ID was added for the scientific contact Maria-Dolores Martínez Romero 11/06/2019: The ORCID ID was added for the scientific contact Dr José Ramón Escuriet-Peiro. 06/06/2019: The following changes were made to the trial record: 1. The plain English summary was up[dated to reflect the change in the inclusion criteria made on 28/05/2019. 2. 16 scientific contacts were added. 28/05/2019: The inclusion criteria have been changed. 12/03/2019: Trial's existence confirmed by the Ministerio de Ciencia, Innovación y Universidades - Institute of Health Carlos III.