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Design of clinical trials

Design of clinical trials

This part of the CLEAR project deals with the preparation and delivery of a clinical manual containing the protocols implemented in the framework of the project CLEAR to provide the clinical service delivered through the Habilis platform.
The design of the clinical trials within the CLEAR project has been reported since it represents a useful experience to be added to the service guidelines and taken into account: i) whenever it is necessary to assess the service impact within the health service it is going to be introduced into; ii) as a guide when new pathologies are to be included within the Habilis TR Service, thus new protocols have to be designed.

The study investigates

  • objectives,
  • design,
  • methodology,
  • statistical considerations,
  • organization

of the clinical trial to be carried out at each clinical centre: MUW, AUSL11, RCR, FPING.
Each protocol deals with the following relevant issues:

  1. background and reason the trial is being conducted. The main objective of the clinical trials is to show the impact of the CLEAR service when being implemented from a clinical point of view and as such focuses on the end users. Impact is in the trials defined as:
    1. satisfaction of end users with the tele-rehabilitation application, both patients and professionals
    2. clinical effectiveness of the service when implemented in terms of health outcome and compliance to tele-rehabilitation
    3. time investment for providing and receiving the tele-rehabilitation service.
  2. the main purpose of the study differentiated within each Centre,
  3. a study plan on which the clinical trial is based. The plan is designed to safeguard the health of the participants. The protocol describes
    1. what types of people may participate in the trial;
    2. the schedule of tests, procedures, medications, and dosages;
    3. the length of the study.
  4. While in a clinical trial, study participants are seen regularly by the research staff (usually medical doctors and/or nurses) to monitor their health and to determine the safety and effectiveness of the treatment(s) they are receiving.

The Protocols are defined in compliance with ICH guidelines for good clinical practice; Good Clinical Practice (GCP) ( ) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected; consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible. This ICH GCP Guideline provides a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions. The guideline was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries and the World Health Organization (WHO). This guideline must be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. The principles established in this guideline may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects (DIRECTIVE 2001/20/EC, see References for further details).

Currently, a Service Manual has been prepared and delivered to all partners of the CLEAR projects. It contains the detailed description of all protocols designed and approved in order to be validated and implemented within the four Clinical Centres involved in the project.
At the end of the project the assessed protocols will be included in the Habilis Telerehabilitation Service guidelines.


A brief summary of the content of the Service Manual is reported here below.
The four clinical centres (AUSL11, FPING, MUW, RCR) will apply the CLEAR telerehabilitation service in their daily care processes for their patients during a large-scale clinical validation trial period. The common objective of the trial is to show the impact of the service when being implemented from a clinical point of view and as such focuses on the end users (patients and professionals). Impact in the trials is defined as:

  1. satisfaction of end users with the telerehabilitation service (patients and professionals)
  2. clinical effectiveness of the service when implemented in terms of health outcome and compliance to treatment;
  3. time investment for providing and receiving the tele-rehabilitation service.

Satisfaction of End Users:

All clinical centres will use the same instrument to assess the satisfaction of end-users with the telerehabilitation service. Since standardized and validated satisfaction questionnaires are scarce in telemedicine literature, a generic ‘cross-centre measure’ to assess the satisfaction with the CLEAR service among the clinical centres is going to be developed within the project based on the Unified Theory of User Acceptance of Technologies. Issues that will be addressed are perceived performance, ease of use, facilitating conditions, and effort expectancy.

Clinical Effectiveness

Due to the different pathologies involved in the study population, the clinical effectiveness is measured by different instruments (i.e. Roland Disability Scale, Attention Behavior Scale, SF-36, kneerelated Quality of Life etc). For every pathology, the clinical effectiveness will be investigated. In addition, on a European ‘cross country’ level it is possible to conduct (statistical) analyses that provide an overall conclusion about the clinical effectiveness of the CLEAR treatment (irrespective of the pathology involved). At each clinical centre, for instance, the percentage of patients which report on a clinical relevant improvement in disability level can be assessed by determining cut of points on the different disability questionnaires used (e.g. Roland Disability scale, Pain Disability Scale, The Knee and Osteoarthritis Outcome Score, Barthel Index). Thus, irrespective of the disability questionnaire applied, the percentage of patients who benefit from the CLEAR telerehabilitation service and the percentage of patients who do not benefit (i.e. no-clinical relevant improvement) can be discerned. The compliance to the treatment (of the different population) will be assessed by means of automatic logging of the frequency and duration of the log-in actions performed by the patient on the Habilis platform. Such data can also be aggregated / put together to give information about the degree of compliance on a European level and the factors which influence compliance.

Time Investment.

The time investment will by assessed by a self-constructed questionnaire developed within the consortium. This questionnaire measures the advantage of the patient of the CLEAR telerehabilitation compared with traditional treatment and the time patients save when they don’t have to travel to the clinic (because they have the opportunity to train at home or at a kiosk).
Since the CLEAR telerehabilitation service will be implemented in routine care and working processes, randomization procedures and the inclusion of a separate control group running in parallel to the intervention group is difficult to organize pragmatically. Therefore, the study design applied by the clinical centres to validate the CLEAR service is an observational prospective cohort study. In the majority of the clinical centres, a historical control group (and dossier research) and/or a separate control group receiving usual care respectively is being set-up to be able to compare the results of the CLEAR intervention with traditional care.
At all clinical centres, baseline, post-test and follow-up measures will be conducted. However, there are differences in time span between the measures and the number of follow-ups due to organizational and pragmatically reasons of the (traditional) rehabilitation care processes.
By means of conducting the validation trials in the different centres including a variety of pathologies, detailed information about the service value can be obtained on both the level of the clinical centres and on a European level. Assessing the impact of the CLEAR telerehabilitation service on both a centre (specific) and a European (generic) level is considered to be valuable from a market validation point of view.