Trial document




drksid header

  DRKS00016077

Trial Description

start of 1:1-Block title

Title

Evaluation of a tele-rehabilitation aftercare program

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The tele aftercare with the online therapy platform Caspar is a concept developed according to the requirements of the German Pension Fund.
The aim of the study is to compare the known face-to-face aftercare measures (e.g. IRENA) of the German Pension Fund and the Tele-Reha aftercare measures using the Caspar online therapy platform.
It will be investigated whether the number of non-responders and dropout rates will decrease after the introduction of tele aftercare.
In addition, it is to be shown that the tele aftercare measure is not inferior to the conventional face-to-face aftercare with regard to various target variables (e.g. health status - subscale IRES).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The tele aftercare online therapy platform Caspar is a concept according to the requirements of the German Pension Fund with the aim of stabilising the health-related behaviour and lifestyle changes introduced during rehabilitation in the long term. Within the research project, the tele aftercare with Caspar will be tested and scientifically accompanied in order to be able to make initial statements about the effectiveness and acceptance of the measure. In addition, potential users will be identified and their acceptance by therapists and patients asked in order to make recommendations on the use of tele-rehabilitation aftercare in standard care.

The following questions arise:
1. has the rate of refuseniks and aftercare dropouts changed after the introduction of tele aftercare?
2. are there differences in the use of the two aftercare measures? Which patients are more likely to take advantage of tele aftercare/face-to-face aftercare and who benefits most from which measure?
3. Which short-term and medium-term effects on the state of health, functional capacity, ability to work and health behaviour result depending on the type of aftercare (tele vs. face-to-face)?
4. how do patients experience tele follow-up? Does it lead to more satisfaction, therapy motivation and loyalty? Does the drop-out rate differ between the two groups?
5. how is tele aftercare accepted by the therapists? Is it perceived as a threat or an opportunity? What difficulties do therapists see in the implementation?
6. has the rate of aftercare refuseniks changed after the introduction of tele aftercare?

Intervention
The intervention will involve the implementation of tele aftercare using the Caspar online therapy platform. This is a browser-based application that enables therapists to send multimedia content to patients as a therapy plan. Currently, the therapist can access more than 650 offers in video and audio format and compile them individually for each patient according to the indication. If required, content can also be created directly by the treating therapist. Training content can be selected from the following modules:
- Movement (training and exercises)
- Education and training
- relaxation
- nutrition
The patient can use the therapy plan created for him on his home PC, tablet or smartphone and is therefore flexible in terms of time and location. All patient exercise activities are documented and the platform enables bidirectional communication between patient and therapist. In addition to time-shifted communication via a feedback function, a direct communication via video chat function can take place if required, e.g. when practicing new therapy contents.

Control
The control group consists of rehabilitants who decide within the observation period to receive face-to-face aftercare or are assigned by randomisation if they receive a follow-up recommendation. The stress normative is identical to the intervention group. The only difference is that the tele-rehabilitation patients carry out the therapy units independently at home and are only in contact with the therapists via the Caspar online platform. The documentation of the treatments takes place in the intervention group via the Caspar platform, in the control group via internal documentation in the facilities.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00016077
  •   2019/05/02
  •   [---]*
  •   yes
  •   Approved
  •   2018-13929-Klinische Forschung, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   multi-modal rehabilitation aftercare
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Orthopedical, neurological or cardiological patients with approved traditional rehabilitation aftercare (usually 24 appointments, 90 to 120 minutes, multimodal therapy).
  •   Orthopedical, neurological or cardiological patients with approved tele-rehabilitation aftercare programm via Caspar online platform.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary targets are the rate of non-responders and the rate of aftercare dropouts.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

At all four measurement points, a standardised questionnaire (IRES-3) is used to record the state of health, functional capability and health behaviour. In addition, rehabilitants are asked about their ability to work (e.g. WAI), their employment status and the severity of their pain.

Subjective health status
The subjective health status is determined using the indicators of rehab congestion (IRES). The IRES is one of the most frequently used generic survey instruments for recording subjective health status. It is used in the field of rehabilitation research to determine the rehabilitation status and to monitor the success of the measure, as well as to compare different forms of therapy.

IRES is ICF-based and examines somatic symptoms and functions, psychological well-being, coping factors and occupational functioning.
A version of the IRES is available for the beginning, the end and the follow-up after rehabilitation. Depending on the time of the survey, the IRES consists of 144, 75 or 125 items. The IRES maps 8 dimensions: 1) somatic health, 2) pain, 3) health behaviour, 4) physical functioning, 5) occupational functioning, 6) psychological well-being, 7) disease management and 8) social integration. The answer format usually consists of a 5-7 level Likert scale (e.g. 1: very strong to 6: not at all 6).

Sociodemographic features
If the relevant sociodemographic characteristics have not already been collected with the IRES, these data will be collected according to the proposals for the sociodemographic core data set in rehabilitation science research.

Treatment satisfaction
It is important that rehabilitants are adequately informed, treated, cared for and prepared for the time after rehabilitation. The extent to which these points are taken into account by the new treatment concept is to be illustrated by recording patient satisfaction. In order to record general treatment satisfaction, the questionnaire for measuring patient satisfaction (ZUF-8) is to be used in a slightly modified form after the end of the aftercare measure. The ZUF-8 operationalises the experienced treatment satisfaction via eight items, which query various aspects of satisfaction using 4-level response scales (e.g. question: "Would you come back to our clinic if you needed help?", possible answers: "clearly not", "I don't think so", "I think so" or "clearly yes").

Further variables
Patients in the intervention group are also asked about the implementation of the treatment, e.g. whether the video instructions and seminars were understandable or whether they would have liked more support or explanations.
Six months after the end of the follow-up measure for t3, the questionnaire also contains questions on the extent to which the rehabilitants are still active in the field of follow-up care.
In order to record not only the patient's but also the therapist's perspective, a global survey of the therapists in the rehabilitation facilities takes place at the end of the observation period. Among other things, difficulties in the implementation as well as the acceptance of the Tele-Reha aftercare are to be recorded.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/05/15
  •   600
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Ability to give consent, sex: male, female, diverse; positive subjective return to work prognosis; performed in- or outpatient rehabilitation according § 15 SGB VI (Volume VI of the German Social Insurance Code); sufficient understanding of the German language; service provider is the German pension insurance of Rheinland-Pfalz

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

performance of less than three hours per day in the general labor market; claim or application of retirement pension of at least then two thirds of the full retirement pension; obtained frequent social benefit until retirement pension

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Insititut für Rehabilitationsmedizinische Forschung an der Universität Ulm (IFR Ulm)
    • Mr.  Prof. Dr. med.  Gert  Krischak 
    • Am Kurpark 1
    • 88422  Bad Buchau
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Helmut Nanz-StiftungKlinik für ambulante Rehabilitation GmbH & Co. KG
    • Mr.  Nikolaos  Gagoudis 
    • Wilhelmsplatz 11
    • 70182  Stuttgart
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • GOREHA GmbH
    • Mr.  Maximilian  Michels 
    • Neue Schönhauser Str. 20
    • 10178  Berlin
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Institut für Rehabilitationsmedizinische Forschung an der Universität Ulm (IFR Ulm)
    • Mr.  Dr. PH  Sebastian  Knapp 
    • Am Kurpark 1
    • 88422  Bad Buchau
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institut für Rehabilitationsmedizinische Forschung an der Universität Ulm (IFR Ulm)
    • Mr.  Dr. PH  Sebastian  Knapp 
    • Am Kurpark 1
    • 88422  Bad Buchau
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • GOREHA GmbH
    • Mr.  Maximilian  Michels 
    • Neue Schönhauser Str. 20
    • 10178  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Insititut für Rehabilitationsmedizinische Forschung an der Universität Ulm (IFR Ulm)
    • Mr.  Prof. Dr. med.  Gert  Krischak 
    • Am Kurpark 1
    • 88422  Bad Buchau
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
  • start of 1:1-Block address otherSupport
    • Nanz medico GmbH & Co. KG
    • Wilhelmsplatz 11
    • 70182  Stuttgart
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.