Trial document




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  DRKS00003322

Trial Description

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Title

Development and Evaluation of an Interactive Health Communication Application for Chronically Ill Patients

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Trial Acronym

[---]*

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URL of the Trial

http://www.forschung-patientenorientierung.de/index.php/projekte/erste-foerderphase/modul-eins-phase-1/infochron-haerter.html

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Brief Summary in Lay Language

We developed online patient information und decision aids (e.g., "Which diabetes or pain medication should I take?") for patients with type 2 diabetes or chronic low back pain. In the study we explore whether patients who receive the information and decision aids in a dialogue-based version that is tailored to their specific needs gain more knowledge on their condition and on how to manage it in their everyday life than patients who receive the same information on a usual website.

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Brief Summary in Scientific Language

We developed patient information und decision aids for patients with type 2 diabetes or chronic low back pain. In an online RCT the intervention group is presented with a tailored, dialogue-based version while the control group receives the same information on a usual website. We research group differences in knowledge, self management and other outcomes.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003322
  •   2012/07/03
  •   [---]*
  •   yes
  •   Approved
  •   PV3412, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   type 2 diabetes
  •   chronic low back pain
  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   M54.5 -  Low back pain
  •   F45.4 -  Persistent somatoform pain disorder
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Interventions/Observational Groups

  •   Information and decision aids on the patient´s condition (type 2 diabetes or chronic low back pain) are presented in a dialogue between the patient and the system. The range and phrasing of both information and decision aids are tailored to
    1) the patient´s condition-specific knowledge
    2) preferred level of detailedness
    3) health behavior:
    a) in type 2 diabetes: attitudes towards self-care (measured using a questionnaire that is based on the Summary of Diabetes Self-Care Activities, SDSCA, Toobert et al., 2000), Barriers to Insulin Treatment (measured using a questionnaire that is based on the arriers to Insulin Treatment Questionnaire, BIT, Petrak et al., 2007),
    b) in chronic low back pain: coping (measured using the questionnaire "Risikoanalyse der Schmerzchronifizierung - Rücken", RISC-R (risc analysis for the chronification of back pain), based on the Avoidance Endurance Model by Prof. Monika Hasenbring, http://www.tpds.de/products/products.htm#RISC_R)
  •   The same information and decision aids as in arm 1 are presented in a usual website with neither dialogue nor tailoring).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Condition-specific knowledge (measured during the intervention and at follow-up 3 months after the intervention with questionnaires that were developed on the basis of the information system)

Empowerment (measured immediateliy after the intervention and at 3 month follow-up with the Health Education Impact Questionnaire HeiQ)

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Secondary Outcome

Use of the intervention (measured via server registrations)

Preparation for Decision Making (measured immediateliy after the intervention in a subsample that is confronted with a medical decision with the Preparation for Decision Making Scale)

Decisional Conflict (measured immediateliy after the intervention in a subsample that is confronted with a medical decision with the Decisional Conflict Scale)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2012/08/01
  •   826
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

self-reported presence of type 2 diabetes or chronic low back pain (with "chronic" being defined as > 3 months). Internet access.

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Exclusion Criteria

absence of the respective diagnosis

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Hamburg-Eppendorf
    • Mr.  Prof. Dr. Dr.  Martin   Härter 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Nina  Weymann 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf
    • Ms.  Nina  Weymann 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/12/31
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Trial Publications, Results and other Documents

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