NCT05992792

Brief Summary

We conducted an implementation research pilot study to assess the adoption, fidelity, appropriateness and acceptability on an intervention to effectively disseminate cancer prevention messages to the public throught a mHealth implementation strategy

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,990

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
Last Updated

August 15, 2023

Status Verified

August 1, 2023

Enrollment Period

3 years

First QC Date

July 12, 2023

Last Update Submit

August 11, 2023

Conditions

PreventionHealth Behavior

Keywords

Cancer preventionmHealthEuropean Code Against CancerHealth Promotion

Outcome Measures

Primary Outcomes (5)

  • Acceptability of preventive intervention

    Rate of acceptability of a future intervention through a telephone survey (ad hoc questionnaire, created by the researchers).

    3 months

  • Adoption of the innovation

    Number of messages expected

    3 months

  • Fidelity to the mHealth implementation strategy

    To assess this outcome measure, the participants will be asked through a telephone survey (questionnaire, created by the researchers) how many messages they have received and if they have read them

    3 months

  • Willingness to seek further information

    Number of visits to the ECAC website

    3 months

  • Perceived utility of the messages

    Rate of participants who consider the received messages useful and understandable. To assess this outcome measure, the participants be asked, by means of a telephone survey (questionnaire, created by the researchers), if they have found the messages they read useful and if they were well understood.

    3 months

Study Arms (4)

App Salud Responde

EXPERIMENTAL

Subjects register in the "Salud Responde" (SR) app services de platform

Behavioral: App message

SMS Salud Responde

EXPERIMENTAL

Subjects register in SR SMS services platform

Behavioral: SMS message

Internet

EXPERIMENTAL

Subjects users with internet in their mobile phone

Behavioral: Internet

Whitout internet

EXPERIMENTAL

Subjects whitout internet to recibe message by SMS

Behavioral: Whithout internet

Interventions

App messageBEHAVIORAL

Participantes push App message cancer prevention from the recomendations ECAC. 2 SMS notifications (push) per week or frequency of app notifications per week.

App Salud Responde
SMS messageBEHAVIORAL

Participants push SMS message cancer prevention from the ECAC. Second randomization for received 2 notifications (push) per week or frequency of 7 SMS notifications per week.

SMS Salud Responde
InternetBEHAVIORAL

Internet connection in their mobile phone and WI-Fi. Participants push message cancer prevention from the recomendations ECAC. Second randomization for received 2 notifications (push) per week or frequency of 7 SMS notifications per week.

Also known as: internet connection
Internet
Whithout internetBEHAVIORAL

Second randomization for received 2 notifications (push) per week or frequency of 7 SMS notifications per week.

Whitout internet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or over, being entitled to health care benefits in Public Andaluz Sanitary System (SSPA in Spanish), user from the User Database (BDU in Spanish) having a mobile phone, and being able to read messages on them.

You may not qualify if:

  • Failing to give informed consent to participate in the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cordoba

Córdoba, 14011, Spain

Location

Related Publications (1)

  • Espina C, Feliu A, Gonzalez Vingut A, Liddle T, Jimenez-Garcia C, Olaya-Caro I, Perula-De-Torres LA. Population-Based Cancer Prevention Education Intervention Through mHealth: A Randomized Controlled Trial. J Med Syst. 2024 Jan 9;48(1):9. doi: 10.1007/s10916-023-02026-y.

    PMID: 38194118DERIVED

MeSH Terms

Conditions

Health Behavior

Interventions

Patient Portals

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Records, PersonalMedical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Officials

  • Carolina Espina

    World Health Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Controlled Clinical Trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 12, 2023

First Posted

August 15, 2023

Study Start

January 1, 2018

Primary Completion

January 10, 2021

Study Completion

July 10, 2022

Last Updated

August 15, 2023

Record last verified: 2023-08

Locations

ES(1)