Patients with chronic diseases require long-term adherence. Adherence can be improved by patient counseling as is common in disease management programs. However, personal counseling is expensive, especially given the fact that chronic patients will…
ID
Source
Brief title
Condition
- Diabetic complications
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adherence to therapy 1) for medication as measured by the system (% of
medication intakes taken) and 2) lifestyle aspects measured via questionnaires
(number of gym visits, amount of physical activities and their intensity,
healthy and unhealthy food consumption).
The ultimate goal is that the system provides an improved adherence to therapy
(both to medication intake and life style changes), eventually resulting in a
reduction in the risk of developing late-stage complications.
Secondary outcome
N.A.
Background summary
Treatment for chronic diseases often consists of a combination of lifestyle
advices and medication. Many patients experience difficulties in following
treatment recommendation. Adherence to these recommendations is often far from
optimal, especially in patients with chronic diseases. Therapy adherence of
patients with chronic diseases ranges between 70-80%. As a result of this
widespread adherence problem, substantial numbers of patients do not get the
maximum benefit of their medical treatment - with poor health outcomes, lower
quality of life and
increased health care costs as a result.
Study objective
Patients with chronic diseases require long-term adherence. Adherence can be
improved by patient counseling as is common in disease management programs.
However, personal counseling is expensive, especially given the fact that
chronic patients will often require treatment for the rest of their life.
Permanent personal counseling is therefore often not realistic. However,
adherence is not a static property and as such, it is likely to decline when
counseling is ended.
In this study, we will evaluate an intelligent online self-monitoring and
self-support system, with the aim of improving adherence to therapy, both with
respect to lifestyle changes and medication intake. This system can be used
within disease management programs as a new element or as long-term follow-up
to support retaining the effects of personal counseling. The objective of this
study is to determine to what extent adherence to oral medication and healthy
lifestyle that comprises physical exercises and healthy food in patients with
type 2 diabetes and HIV patients can be improved with ICT tools: Real Time
Medication Event Monitoring System (electronic monitoring of medication use),
model of behaviour change, combined with an SMS interaction system and Internet
technologies. The elements of the model and the system are meant to be
generally applicable to chronic diseases.
Study design
First, a pilot study with 40 patients will be done to validate the model and
fine-tune the application. Then the hypothesis of improved therapy adherence
with the help of the electronic system will be tested in two controlled
studies, in which the adherence to therapy of 150 chronic patients that use the
system is compared to the adherence of 150 patients that receive the usual
treatment. Both chronic patients group as the control group will consist of 75
HIV patients and 75 diabetes type 2 patients.
Intervention
The intervention groups use the complete system (mobile phone app, website,
electronic pillbox) and get tailored information; the control groups use the
electronic pillboxes and get a link to general information about the importance
of therapy adherence for their disease.
Study burden and risks
The patients will fill two times questionnaires on physical activity and diet:
one time in the beginning of the study and one time in the end. They will also
answer short questions via a mobile phone or a web-site during the intervention
maximum. The maximal number of questions per day will be determined by the
preferences of each individual participant.
The burden of the study is very low: the participants have to read the messages
sent by the system via a mobile phone or on the web-site and periodically
answer the questions posed by the system.
There are no risks involved.
De Boeleaan 1081
1081 HV Amsterdam
NL
De Boeleaan 1081
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for diabetes patients are: 1) using oral antidiabetics >1 year; 2) using an Android-based smart phone; 3) using a personal computer with the Internet connection.
Inclusion criteria for HIV-patients are: 1) using combination antiretroviral therapy for > 1 year; 2) using an Android-based smart phone; 3) using a personal computer with the Internet connection.
Exclusion criteria
Exclusion criteria for both patients groups are: 1) age > 65 years; 2) age < 18 years; 3) not speaking Dutch; 4) analphabetic
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 | NL34393.029.11 |