Relapse after an intensive rehabilitation program is a problem, the additional intervention which is developed aimed to prevent this. The intervention is innovative and no alternatives are known in the literature.The following practical questions…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronische musculo-skeletale pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) The degree of relapse, relapse is defined here as the patient's inability to
retain the profit made in the area of daily functioning during rehabilitation.
The Pain Disability Index and the Pain Self Efficacy Questionnaire (Van der
Maas. 2012) from the Dutch Pain Rehabilitation Data Set are used as an outcome
measure.
Secondary outcome
Fear avoidance beliefs (FABQ), Self efficacy (PSEQ), illness perception (IPQ-k)
and psychological flexibility (PIPS) are viewed as mediators. In addition,
healthcare consumption is monitored by completing a cost diary.
Background summary
Chronic pain is defined as pain that lasts longer than three months, or lasts
longer than the expected time for recovery from damage or illness. Compared to
other chronic conditions, chronic pain is common. Chronic pain is a complex and
expensive problem. Chronic pain has a major impact on quality of life, daily
functioning, mood and absenteeism. One in 5 adult Dutch people (2.25 million )
experience chronic pain. With low back pain, for example, recurrent complaints
are very common and regularly develop into a chronic problem (Hartvigsen J
2018). Chronic pain costs Europe billions of euros: almost ¤ 300 billion or
around 1.5-3% of GDP. There is currently no treatment that completely resolves
chronic pain. At the momentThe best treatment for chronic pain treatment aimed
at self-management.. In the "Zorgstandaard Chronische Pijn (2016)", pain is
defined as a multi-factorial problem in which the cooperation between primary
care and secondary care is strongly advocated (Stepped Care model).
Effects of pain rehabilitation give positive results on pain perception and
physical and mental functioning. However, these are described particular in the
short term. In the longer term, 30-70% of patients appear to relapse and seek
care for their pain problem again. Remarkably little scientific research has
been done on the long-term effects of a pain rehabilitation program(Morley
2008). In a recent study in the Netherlands into the long-term effects of 15
weeks of pain rehabilitation, between 37% and 55% of patients reported a
clinical improvement in the event of discharge, which after a year of follow-up
appeared to be constant. However, some of the patients also experienced a
relapse (Volker et al 2017). Currently a study is under construction on the
long-term effects and relapse of three Dutch pain rehabilitation centers
(SOLACE study).
The main goals of pain rehabilitation are learning to deal with pain
differently (behavioral change) and promoting self-management. During the
treatment, the patient is taught skills to ultimately "be able to do it
himself." In addition, the rehabilitation centers have been reluctant to offer
much aftercare because this could possibly have the opposite effect on the
degree of self-management of a patient. That is why, up to now, often no or
only limited formal aftercare has been arranged. At the same time, it is known
that patients regularly return to rehabilitation centers with the request for
help for renewed support or help with relapse. A new treatment process is then
often started. The SOLACE study (SIA RAAK public 2014-02-23P) showed that
patients need more support to perpetuate the results of their rehabilitation
and prevent relapse.
The SOLACE consortium has developed two interventions with which relapse can be
prevented. Both are elaborated in the form of a workbook that is used during
the treatment and that facilitates and supports the application of acquired
skills after the treatment.
* The first intervention, Do It Yourself (DIY), facilitates the registration of
all important events and insights that the patient experiences during
rehabilitation. These insights can then be used to a) check whether they are in
line with the rehabilitation program; b) create a timeline to jointly evaluate
progress; and c) to be used as a reference work after the rehabilitation.
* The second intervention consists of a scheme that helps patients formulate
value-oriented goals (WD) and then plans and monitors these goals step by step.
The applicability and user-friendliness of the workbook has been evaluated
(feasibility). However, the long-term effectiveness of these prototypes has not
yet been investigated. The question clearly emerged during the feasibility
study, in addition to the question about the shape of the workbook, paper or
digitally via an app.
The current application (Agrippa) combines both intervention modules and
relates to the effectiveness of the additional intervention in the form of an
app.
Study objective
Relapse after an intensive rehabilitation program is a problem, the additional
intervention which is developed aimed to prevent this. The intervention is
innovative and no alternatives are known in the literature.
The following practical questions were formulated in consultation with care
professionals, rehabilitation institutions and patients' associations;
* Are the interventions developed from SOLACE study that are used after an
intensive rehabilitation period, in the long term, 6 to 12 months, effective to
prevent relapse and medical shopping?
* Is the digital application, Agrippa app, of the developed intervention as
useful as it is effective?
By answering these two practical questions, the consortium aims to contribute
to the development of an optimal rehabilitation process for chronic pain
patients.
Study design
A multi center randomized clinical trial. Randomisation is at group level.
Intervention
Agrippa app; Application on the smartphone with the content developed in an
earlier study (SOLACE) based on general self-regulation principles with the aim
of transferring crucial treatment insights to the patient's personal context.
Study burden and risks
The population undergoes the normal rehabilitation process, the intervention
group receives an application for the smartphone, there are no risks involved.
The advantage of using the app is that patients themselves can reverse a
relapse by easily retrieving the set goals and values via text, image and / or
sound so that they can also retrieve the positive experiences within regular
rehabilitation and later after the rehabilitation (themselves management).
The load depends on the usage, can be a daily or in a much lower frequency.
Heidelberglaan 7
Utrecht 3584CS
NL
Heidelberglaan 7
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
Chronic Pain Patients qualified for a intensive rehabilitation program in the
secundary care defined as patient with a classification WPN 3 and 4 ( Werkgroep
Pijnrevalidatie Nederland); social and psychological factors are complex to
very complex and play an important role
Exclusion criteria
Chronic pain patient not classified as WPN 3 or 4. Patients with specific
complaints like rheumatoid arthritis, carcinoma, stroke etc
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 | NL69066.041.19 |