Promoting access to rehabilitation

Organizational Data

DRKS-ID:
DRKS00005658
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2014-09-16
Last update in DRKS:
2016-10-10
Registration type:
Prospective

Acronym/abbreviation of the study

PROREHAB

URL of the study

No Entry

Brief summary in lay language

The study examines the efficacy of a web-based information portal that addresses persons with a high risk of health-related early retirement to facilitate their access to medical rehabilitation. The website will offer the opportunity to assess the need for rehabilitation in order to promote the intention to apply for a medical rehabilitation of persons with limited work ability and will support handling and submission of the required application documents by a step-by-step instruction. The efficacy of the web-based information portal will be investigated in a controlled trial. Participants will be randomly allocated to two groups: written information on the possibility to use medical rehabilitation including the invitation to use the web-based information vs. written information only. We expect that participants with an access to the web-based information portal apply for and utilise medical rehabilitation services more often than comparable persons who receive written information only.

Brief summary in scientific language

In Germany, persons can request medical rehabilitation (MR) to improve work ability and participation in working life. A particular target group of these services are persons with a high risk of health-related early retirement, e.g. persons who received sick leave benefits. However, if need for rehabilitation does not lead to a formal rehabilitation request, this legal opportunity to keep handicapped people in working life remains unused. In 2011, 59.6 % of all male pensioners and 52.7 % of all female pensioners did not use MR before their health-related early retirement. In our study, the effects of a web-based information guide on medical rehabilitation, which addresses persons with prior sick leave benefits, will be examined. The theoretical framework of this web-based guide is based on Schwarzer’s Health Action Process Approach. This model distinguishes two phases when realising health-related behaviour: a motivational (forming an intention) and a volitional phase (acting). The website will offer the opportunity to assess the need for rehabilitation by completing the Work Ability Index. In cases of low Work Ability Index scores persons will be advised to apply for a medical rehabilitation. Handling and submission of the required application documents will be supported by a step-by-step instruction. The efficacy of the web-based information portal will be investigated in a randomised controlled trial. Participants of the intervention group will be informed on the aims of MR and the opportunity to use MR. Additionally, a link to the web-based information will be provided. Participants of the control group will receive a short hint on the opportunity to request this service. We expect that participants who will have access to the web-based information portal apply and use MR more frequently than participants of the control group.

Health condition or problem studied

Free text:
Persons with sick leave benefits in 2013
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Participants of the intervention group receive a short hint on the possibility to apply for a medical rehabilitation. Additionally, the link to the web-based information portal will be provided.
Arm 2:
Participants of the control group receive a short hint on the possibility to apply for a medical rehabilitation.

Endpoints

Primary outcome:
Primary outcome is the proportion of applied and utilised medical rehabilitation services after one year. These data will be extracted from the individual German Pension Insurance (GPI) accounts.
Secondary outcome:
Secondary outcomes are days with sick leave benefits and days of regular employment during the one-year follow-up. These data will be also extracted from the individual GPI accounts. Further secondary outcomes will be assessed by questionnaire after one year. These outcomes include cognitions on rehabilitation and the application (positive and negative outcome expectancies, self-efficacy; own development, see DRKS00004824), indicators of health-related quality of life (subscales of the 36-item Short-Form Health Survey: physical functioning, mental health, general health perception), individual work ability and disability days.

Study Design

Purpose:
Health care system
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Other Deutschland

Recruitment period and number of participants

Planned study start date:
2014-09-22
Actual study start date:
2014-09-22
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
16000
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
40 Years
Maximum Age:
59 Years
Additional Inclusion Criteria:
Persons aged 40 to 59 years with prior sick leave benefits and regular employment of at least six months in the year before the beginning of the study will be included. Samples will be drawn from the registers of three pension insurance agencies (Federal German Pension Insurance, German Pension Insurance Westfalen and German Pension Insurance Rheinland-Pfalz). Sampling will be stratified for pension insurance agency, sex and duration of sick leave benefits.

Exclusion Criteria

receipt of pension benefits; receipt of rehabilitation services during the last four years

Addresses

Primary Sponsor

Address:
Deutsche Rentenversicherung Bund
Marco Streibelt
Hohenzollerndamm 46/47
10713 Berlin
Germany
Telephone:
+4903086581591
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.deutsche-rentenverischerung-bund.de
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
Institut für Sozialmedizin und Epidemiologie
Prof. Dr. Matthias Bethge
Ratzeburger Allee 160
23562 Lübeck
Germany
Telephone:
+4945150051280
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Address:
Deutsche Rentenversicherung Bund
Dr. Marco Streibelt
Hohenzollerndamm 46/47
10713 Berlin
Germany
Telephone:
+4903086581591
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.deutsche-rentenverischerung-bund.de

Principal Investigator

Address:
Institut für Sozialmedizin und Epidemiologie
Prof. Dr. Matthias Bethge
Ratzeburger Allee 160
23562 Lübeck
Germany
Telephone:
+4945150051280
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Deutsche Rentenversicherung Bund
Ruhrstraße 2
10704 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Address:
Ethikkommission der Medizinischen Hochschule Hannover
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
+49-511-5323443
Fax:
+49-511-5325423
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2013-11-20
Ethics committee number:
2060-2013
Vote of the Ethics Committee:
Approved
Date of the vote:
2013-11-22

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1134-6350
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Spanier K, Streibelt M, Unalan F et al. A web-based intervention to promote applications for rehabilitation: a study protocol for a randomized controlled trial. Trials 2015;16:436; 10.1186/s13063-015-0968-7
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry