The first objective is to evaluate if the online aftercare program is more effective when it is supported by e-mail contact with a health care professional compared to no support in decreasing interference of pain complaints with daily life. Theā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
chronische pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study outcome is pain interference measured at 3 month follow-up.
Secondary outcome
Secondary study parameters are pain intensity, psychological distress and
psychological flexibility at 3 months follow-up..
Outcomes of the qualitative part are user experiences and the opinions of
participants concerning support by a health care professional.
Background summary
Many chronic pain patients find it difficult to retain behavior changes after
multidisciplinary pain rehabilitation program. They experience barriers in
living according to their personal values and to realize a balanced daily
activity schedule in the presence of pain or negative thoughts. An aftercare
program that prevent relapses is needed but not routinely offered due to
limited therapist time and a lack of (financial) resources. A relapse
prevention program based on e-health might overcome these barriers. Thus far,
it is unknown whether patients can use the program on their own or whether a
minimum of professional support is needed.
Study objective
The first objective is to evaluate if the online aftercare program is more
effective when it is supported by e-mail contact with a health care
professional compared to no support in decreasing interference of pain
complaints with daily life.
The secondary aim is to assess the clinical benefits of the online program on
the outcomes pain intensity, psychological distress and the process variable
psychological flexibility.
The third objective is to qualitatively evaluate the experiences of a subsample
of 20 participants while using the program and to assess their opinions
concerning support of a health care professional.
Study design
The design is a randomised controlled superiority study with two conditions. In
the experimental condition patients get access to the online aftercare program
and to a contact module that enables them to exchange e-mails with a healthcare
professional. In the control condition patients only get access to the online
aftercare program.
In addition, a qualitative study will be done with a subsample of 20
participants from both the experimental and control condition.
Intervention
The intervention consists of a psychosocial module, a physical module and a
contact module in the experimental condition. The psychosocial module based on
Acceptance & Commitment Therapy. The website and mobile application aim at
sustaining valued actions. The physical training program consists of films and
instructions of physical exercises that can be adapted individually. The
contact module offers the opportunity to exchange e-mails in a safe
environment. Participants are free to send as much e-mails as they want, the
healthcare professional reacts once a week.
Study burden and risks
Participants who receive the online aftercare program can gain direct benefit
from participation in this study, as the program is expected to prevent
relapse. No risks are expected from participation in this study. Questionnaires
used in the study are non-invasive and they are part of the standard
measurement procedures of Roessingh Rehabilitation Centre. Additionally, no
drugs or physical procedures are involved in the protocol.
Telephone interviews in the qualitative part take 30 minutes at the most.
Roessinghbleekweg 33b
Enschede 7522 AH
NL
Roessinghbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
* Patients aged between 18 and 65 years old
* Primary complaint is chronic musculoskeletal pain
* Having finished a pain rehabilitation treatment at RCR
* Being able to use an online program
* Disposal of a smartphone, I-pad or PC
* Permission to use data for scientific purposes
Exclusion criteria
There are no exclusion criteria for including participants into the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
Other | 23539 |
CCMO | NL55824.044.15 |
OMON | NL-OMON27656 |