An online aftercare programme to improve vocational reintegration after inpatient medical rehabilitation

ISRCTN ISRCTN33957202
DOI https://doi.org/10.1186/ISRCTN33957202
Secondary identifying numbers 0423/00-40-65-50-25
Submission date
15/08/2011
Registration date
27/10/2011
Last edited
30/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Mental and psychosomatic disorders are the leading reasons for work disability and premature pension in Germany and in most other high-income countries. In our previous studies we showed that job-specific interventions during in-patient rehabilitation, like real workplace training or stress management training, could be helpful to improve treatment satisfaction. Patients taking part in these programmes could also improve their vocational reintegration after inpatient rehabilitation. Currently we don’t know how patients could transfer these improvements into their daily work. In most studies the improvements achieved during an inpatient rehabilitation treatment fade over time. Most patients are back to their initial health status 12 months after discharge from inpatient rehabilitation.
Aftercare programmes do exist but are not commonly known or accessible. Therefore, the internet offers new possibilities for special internet-based treatments (e.g. counselling interventions). This is groundbreaking because the internet is widely used, with 73.3% of the German population using the internet on a regular basis. The main aim of our study is to analyse if an internet-based aftercare programme could improve vocational reintegration after inpatient rehabilitation. In particular, we want to show if our aftercare programme could help to stabilise the improvements achieved during inpatient rehabilitation concerning subjective vocational stresses as well as health status of participating patients.

Who can participate?
Patients aged 18 to 59 years who are admitted to the participating rehabilitation units because of psychosomatic, orthopaedic and cardiovascular complaints.

What does the study involve?
Patients will be recruited through information from health professionals at the participating rehabilitation clinics at admission to the inpatient rehabilitation treatment. Those who are interested will receive written information about the study. After giving their informed consent 800 patients who meet the above requirements can participate.

Patients will be randomly allocated into one of two groups: the intervention group or the control group. If you are allocated to the intervention group you will get an internet-based aftercare programme following the inpatient treatment. The internet-based aftercare programme consists of: a section with information material to download, a moderated forum, a self-test, and a weekly blog concerning different situations at your workplace, with a commentary from an online therapist. If you are allocated to the control group you will also get access to an internet-based aftercare programme that consists of information material to download concerning stress management, physical training, health behaviour and relaxation techniques.

What are the possible benefits and risks of participating?
The expected benefits of taking part in this aftercare programme include stabilised improvements concerning stress management, coping with conflicts at work and improved vocational reintegration.
There are no known risks to participants.

Where is the study run from?
There are four participating clinics in Germany and the analysing centre is at the University Medical Centre Mainz, Department of Psychosomatic Medicine and Psychotherapy.

When is the study starting and how long is it expected to run for?
The study is running from November 2010 until October 2013.

Who is funding the study?
German Statutory Pension Insurance.

Who is the main contact?
Dr Rüdiger Zwerenz
ruediger.zwerenz@unimedizin-mainz.de

Study website

Contact information

Dr Rüdiger Zwerenz
Scientific

University Medical Center of the Johannes Gutenberg-University Mainz
Department for Psychosomatic Medicine and Psychotherapy
Untere Zahlbacher Str. 8
Mainz
D-55131
Germany

Email ruediger.zwerenz@unimedizin-mainz.de

Study information

Study designMulti centered, prospective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDevelopment and evaluation of an internet-based aftercare programme to improve vocational reintegration after inpatient medical rehabilitation
Study objectivesIn this study we develop and evaluate an internet-based aftercare programme after inpatient medical rehabilitation, with hypotheses as follows:
1. We expect that vocationally strained patients taking part at the internet-based aftercare programme could stabilise the improvements achieved during inpatient rehabilitation concerning stress management and coping with conflicts at the workplace more than the "treatment as usual" control group, resulting in an improved vocational reintegration
2. We expect these effects to be evident up to nine months after the end of the internet-based treatment

On 23/08/2013 the anticipated end date was changed from 31/10/2013 to 31/05/2014.

On 03/07/2014 the anticipated end date was changed from 31/05/2014 to 31/08/2014.
Ethics approval(s)Medical association of Rhineland-Palatinate Ethics Committee, Mainz [Landesärztekammer Rheinland-Pfalz], 12/01/2011, ref: 837.415.10 (7424)
Health condition(s) or problem(s) studiedVocationally strained patients in psychosomatic, orthopaedic and cardiovascular rehabilitation
InterventionWith a cluster randomised controlled intervention study we intend to study overall 800 patients at the beginning (T0) and at the end (T1) of inpatient medical rehabilitation as well as at the end of the aftercare programme (3 months after T1) and 9 months later (12 months after T1).

Patients in the intervention group get the internet-based aftercare intervention, based on a manualised, educational vocational training (“Health training stress management at the workplace”) they attended during inpatient rehabilitation. Patients of the control group also attend the inpatient training and do not get the special internet-based aftercare programme but obtain access to a placebo internet-based programme (with links to public accessible information about stress management and coping).
Intervention typeOther
Primary outcome measure“Social medical risk index “ in the screening questionnaire SIBAR (Bürger & Deck, 2009) at follow-up, including subjective prognosis for work, time of sick leave and unemployment as well as wish for pension.

Timepoints:
Screening = T0 = 0 months
Baseline = T1 = after the vocational training (about 3-6 weeks after screening)
End of treatment = T2 = 3 months after baseline diagnostics
Follow-up = T3 = 12 months after baseline diagnostics
Secondary outcome measuresLevel of vocational distress, physical and mental health and capability at follow-up.

Timepoints:
Screening = T0 = 0 months
Baseline = T1 = after the vocational training (about 3-6 weeks after screening)
End of treatment = T2 = 3 months after baseline diagnostics
Follow-up = T3 = 12 months after baseline diagnostics
Overall study start date01/11/2010
Completion date31/08/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit59 Years
SexBoth
Target number of participants800
Key inclusion criteriaVocationally strained patients in psychosomatic, orthopaedic and cardiovascular rehabilitation:
1. Private internet-access
2. Aged 18-59 years
2. Current occupation (full time, part time)
3. Vocational distress or high demand for vocational training / therapy according to the screening
4. German-speaking
Key exclusion criteria1. Unemployment, pension or no plans to work (e.g. housekeeping) at the beginning of inpatient rehabilitation
2. Severity of physical or psychological complaints, so that it is not possible to take part at the inpatient stress management training
Date of first enrolment01/11/2010
Date of final enrolment31/08/2014

Locations

Countries of recruitment

  • Germany

Study participating centre

University Medical Center of the Johannes Gutenberg-University Mainz
Mainz
D-55131
Germany

Sponsor information

German Statutory Pension Insurance (Deutsche Rentenversicherung Bund) (Germany)
Government

Funders

Funder type

Government

German Statutory Pension Insurance (Deutsche Rentenversicherung Bund) ref: 0423/00-40-65-50-25

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 25/01/2013 Yes No
Results article results 08/05/2017 30/01/2019 Yes No

Editorial Notes

30/01/2019: Publication reference added