Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05992792 |
| Other study ID # |
AP-0176-2018 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2018 |
| Est. completion date |
July 10, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
Hospital Universitario Reina Sofia de Cordoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Description:
A type-2 hybrid effectiveness-implementation study was designed to primarily test the impact
of a mHealth implementation strategy on implementation outcomes (e.g., adoption, fidelity of
intervention delivery) while simultaneously gathering information on the effectiveness of the
intervention. The feasibility single-blind randomised controlled trial has been carried out
on a sample of the general population in the Autonomous Community of Andalusia, the most
populated region of Spain, with more than 8.5 million residents (17.9%). The Andalusian
Health Service (SAS, acronym in Spanish) is the main healthcare provider of the Andalusian
Public Health System (SSPA, acronym in Spanish), part of the decentralised Spanish National
Health System, which provides free universal health insurance. The SAS oversees "Salud
Responde" (SR, acronym in Spanish), a multi-channel platform that provides a broad online
portfolio of services to respond to health-related issues and administrative management needs
of citizens and health professionals, complementing the care provided by the health care
units. It allows 24 hours a day access to the services and benefits of the SSPA, from any
point in Andalusia, through telephone, e-mail, short message system (SMS) and a mobile
application (app) to manage appointments and reminders, and to disseminate personalized
health information. The app has a high coverage with more than 5.7 million users (67% of the
Andalusian's population) registered in its system in 2023; yet the SR platform maintains the
information system service via SMS for specific campaigns to those users who do not have or
want the app installed on their mobile phone (around 9700 registered users).
The inclusion criteria were being 18 years or over, being entitled to health care benefits in
SSPA, having a mobile phone, and being able to read messages on them. A sample of 1991 users
from the User Database (BDU, in Spanish) of the SSPA, that in 2019 included more than 8.5
million users (REF), was used to randomly assign subjects to the different groups. The first
randomization was performed according to the recruitment procedure (users registered or not
in the SR platform) and the technology used to disseminate the messages (app or SMS). Group 1
(G1), subjects registered in the SR app service platform, and Group 2 (G2) subjects
registered in the SR SMS service platform, were recruited through phone call. The rest of
subjects needed to reach the target sample size were recruited from those included in the BDU
database through a phone call. A maximum of eight attempts were done before considering no
response. To be able to calculate participation rate (positive response rate + acceptance to
participate), no replacement was performed.
For those not registered in the SR platform who accepted to participate in the study, a
further distribution was done based on a discriminatory question: those users with internet
connection in their mobile phone both through 3G/4G and Wi-Fi were allocated in Group 3 (G3)
and encouraged to download the app to receive messages, and those without internet were
allocated in Group 4 (G4) to receive messages by SMS. Informed consent to participate was
requested for tehe investigators and the voluntary and anonymous nature of the participation
was ensured. The simple randomisation to the different study groups was performed using the
EPIDAT 4.0 programme. The second randomization was performed based on the messages' delivery
frequency: frequency of 2 SMS or 2 app notifications ("push") per week, or frequency of 7 SMS
or 7 app notifications per week.
Intervention After the second randomisation, an intervention was conducted for 4 weeks where
participants were sent app push notifications or SMS messages via the SR platform. Each push
notification or SMS message included a cancer prevention recommendation from the ECAC 4th
edition (in Spanish) from the following list: "Don't smoke. Do not use any type of tobacco";
"Maintain a healthy weight"; "Exercise daily. Limit time spent sitting"; "Eat lots of whole
grains, legumes, fruits and vegetables"; "Limit high-calorie foods (foods rich in sugar or
fat) and avoid sugary drinks"; "Avoid processed meat; limit consumption of red meat and
salt-rich foods"; "Limit alcohol consumption, although it is best for cancer prevention to
avoid alcoholic beverages"; and the URL link to visit the Spanish version of the ECAC's
website to consult additional information, through the mobile phone or other digital device.
All messages were endorsed and signed by the Head of the Andalusian Regional Ministry of
Health.
Data collection was conducted for the investigators at two time points: at baseline during
the recruitment call, a pre-intervention survey was performed to gather basic
socio-demographic and patterns of use of new technologies (e.g., type of mobile device,
internet access from phone or computer, etc.); at the end of the intervention, from one week
to one month after receiving the last message, a post-intervention survey was carried out by
telephone to all participants.
Variables and categorization The sample was described for the investigators according to the
following socio-demographic variables of the participants: sex, age, employment status, level
of education, living alone or not, and province of residence. The mHealth-related variables
included were the type of mobile phone, access to the Internet through the mobile phone or
other digital device, permanent access to Internet data or only through Wi-Fi, ability to
browse on the Internet and from which type of device, and willingness to receive messages in
the future (acceptability of a future intervention). The survey questions were structured for
the investigators to estimate intervention-related variables: the adoption of the innovation
(number of messages read) for the participants, the fidelity to the mHealth implementation
strategy (receiving and reading the number of messages expected), the preferred frequency and
time to receive messages, willingness to seek further information (number of visits to the
ECAC website), and perceived utility and understandability of the messages.
Statistical analysis The sample size was calculated for the investigators considering a
confidence level of 95% (5% alpha error), a precision of 5% (width of the confidence
interval), an expected proportion of 50% (maximum indeterminacy) in the main variables from
the Conceptual Framework for Implementation Outcomes (adoption, fidelity, appropriateness,
and acceptability), and a non-response rate of 5%.
Participation rate was considered for the investigators an outcome and therefore calculated
as the rate of those who accepted participate in the study among all those who responded to
the recruitment call. A descriptive analysis was performed for the investigators to assess
homogeneity across groups by sociodemographic data by means of relative frequencies, using
Chi-square test for categorical covariates and t-tests for continuous covariates, in the
univariate analysis. The sample was also described at follow-up, according to
socio-demographic data and patterns of mHealth use by messaging channel. The implementation
research outcomes of adoption, fidelity, appropriateness, and acceptability, and willingness
to visit the ECAC's website (coded as a form of adoption) for the participants, were
calculated with relative frequencies by dissemination channel and intervention group.
Finally, a multivariate logistic regression was conducted to characterize the participant
socio-demographic characteristics associated with having read at least one message weekly.
Crude and adjusted Odds Ratios (cOR and aOR) and its 95% confidence intervals (95% CI) were
calculated. Significant association was defined with p≤0.05. STATA 17.0 and SPSS V.21.0. were
used in the analysis.
