To test whether the Emma-app and/or a financial incentive can improve therapy adherence, clinical disease outcomes and quality of life in adolescents and young adults with a chronic health condition.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Meerdere chronische aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in adherence rates from baseline to endpoint and between the
different groups.
Secondary outcome
The difference in clinical disease outcomes and quality of life from baseline
to endpoint and between the different groups.
Cost-effectiveness analysis of the study.
Background summary
Many people suffer from a chronic health condition requiring daily medication
intake, which affects them in their daily lives. To be adherent to therapy is
important but difficult, especially for adolescents and young adults. Less than
half of the chronically ill adolescents is adherent to therapy. Non-adherence
leads to more comorbidities, increased health utilization with the additional
higher costs and higher mortality rates. Many interventions to improve
adherence have been evaluated, but no long-lasting solution has been found yet.
In this modern age, where technology is more and more important, e-health seems
promising to enhance several health outcomes. The Emma-application runs on a
smartwatch and is a combination of a reminder- and monitoring system. What
makes this app so unique, is the possibility to add a social community to give
extra support to the patient. Financial incentives have shown great promise in
previous research to change behavior and to enhance adherence. Adolescents seem
to be very receptive for incentives and rewards.
In this study we will evaluate if the combination of the Emma-app and a
financial incentive can improve therapy adherence, disease outcomes and quality
of life in adolescents and young adults with a chronic health condition, on
daily treatment.
Study objective
To test whether the Emma-app and/or a financial incentive can improve therapy
adherence, clinical disease outcomes and quality of life in adolescents and
young adults with a chronic health condition.
Study design
This multicenter study will be conducted in three phases. The first phase is a
prospective, longitudinal cohort study, with a duration of one year. The second
phase is a single blinded, randomized controlled trial, with a duration of six
months. The third and last phase is a follow-up period with a duration of six
months.
Intervention
All participants will receive standard care. No extra visits or medical tests
are necessary. After inclusion (at baseline), study participants will be
monitored for six months. After six months, (T1), all study participants will
receive a smartwatch, which has the Emma-app installed. After one year (T2),
all non-adherent patients will be randomized into two groups: the first group
will receive a financial incentive in the event of optimal adherence for six
months. The second group will not receive this incentive. After 18 months there
will be a follow-up period of six months to evaluate whether the effect of the
financial incentive will last. The study will end after 24 months (T4).
Study burden and risks
The study participants will be asked to fill out Quality of life questionnaires
on five occasions; at T0, T1, T2, T3 and T4. There are no extra hospital visits
or medical tests required to participate. There are no risks associated with
participation in this study. The extra burden is negligible.
Meibergdreef 5
Amsterdam 1105AZ
NL
Meibergdreef 5
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Patients are adolescents and young adults (12-30 years old)
Patients have a chronic somatic disease
Patients use medication daily
Patient own a smartphone with an android- or ios-based operating system.
Patients have to choose a buddy.
Written informed consent of the participants and legal guardians (when underage)
Exclusion criteria
Patiënts that have a psychiatric condition, not a somatic disease.
Patiënts that do not have sufficient knowledge of the Dutch language.
No signed informed consent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62591.018.17 |