Trial document




drksid header

  DRKS00001901

Trial Description

start of 1:1-Block title

Title

Individualized patient information following patient's illness beliefs and treatment beliefs in the context of rehabilitation

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

Patient information is a central element of rehabilitation care. However, patients are often dissatisfied with received information. Therefore, the aim of this study was to develop an intervention to tailor patient information to the individual needs of patients considering their illness beliefs and treatment beliefs as well as their satisfaction with information about illness and treatment. The intervention took an individual approach in which the content of each patient’s intervention was based on an individual assessment of the patient’s illness and treatment perceptions and information needs. The tailored information was delivered during rehabilitation care. As a guide for tailoring the information, physicians and psychologists of the rehab centres received a “feedback form” that provided information about the patients’ illness and treatment beliefs and information needs. The intervention was implemented and evaluated in nine cooperating inpatient rehabilitation centres for musculoskeletal diseases and psychosomatics.

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

Brief Summary in Scientific Language

Patient information is a central element of rehabilitation care. However, patients are often dissatisfied with received information. Therefore, the aim of this study was to develop an intervention to tailor patient information to the individual needs of patients considering their illness beliefs and treatment beliefs as well as their satisfaction with information about illness and treatment. The intervention took an individual approach in which the content of each patient’s intervention was based on an individual assessment of the patient’s illness and treatment perceptions and information needs. The tailored information was delivered during rehabilitation care. As a guide for tailoring the information, physicians and psychologists of the rehab centres received a “feedback form” that provided information about the patients’ illness and treatment beliefs and information needs. The intervention was implemented in nine cooperating inpatient rehabilitation centres for musculoskeletal diseases and psychosomatics. The evaluation followed a prospective study design with three measurement points.

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

Organizational Data

  •   DRKS00001901
  •   2011/11/16
  •   2008/03/20
  •   yes
  •   Approved
  •   033/08, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   UKF001463  (Register klinischer Studien des Universitätsklinikums Freiburg)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   M40-M54 -  Dorsopathies
  •   F33 -  Recurrent depressive disorder
  •   F34.1 -  Dysthymia
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention group: Individualized patient information following patient's illness beliefs and treatment beliefs
  •   control group (care as usual)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

health status/quality of life; functioning

Operationalization: SF-36; Oswestry disability index; Allgemeine Depressionsskala

measurement point: start of rehabilitation, end of rehabilitation, 6-months-follow up

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

Secondary Outcome

satisfaction with information about medicine, illness and rehabilitation; perceived involvement; adherence

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2008/03/02
  •   400
  •   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

age > 18 years; informed consent; German speaking; adequate cognitive and physical functioning; ICD-10 F32, F33, F34.1; ICD-10 M40-M54

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

Exclusion Criteria

Generic: on-going early retirement proceedings; Depressive disorders: bipolar disorder, acute suicidal tendency, addiction, disorientation; Chronic Back Pain: disc surgery within the last 6 months, indication of an inflammatory or neoplastic origin, orientation disorders and psychiatric illnesses.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Abteilung Qualitätsmanagement und Sozialmedizin, Universitätsklinikum Freiburg
    • Ms.  Dr.  Manuela  Glattacker 
    • Engelbergerstraße 21
    • 79108  Freiburg
    • 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 scientific-contact
    • Abteilung Qualitätsmanagement und Sozialmedizin, Universitätsklinikum Freiburg
    • Ms.  Dr.  Manuela   Glattacker 
    • Engelbergerstraße 21
    • 79106  Freiburg
    • 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
    • Abteilung Qualitätsmanagement und Sozialmedizin, Universitätsklinikum Freiburg
    • Ms.  Dr.  Manuela  Glattacker 
    • Engelbergerstraße 21
    • 79106  Freiburg
    • 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
    • Deutsche Rentenversicherung Bund
    • 10709  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
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2011/04/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Glattacker M, Heyduck K, Meffert C. Illness beliefs, treatment beliefs and information needs as starting points for patient information - evaluation of an intervention for patients with chronic back pain. Patient Education and Counseling. Epub ahead of print (DOI 10.1016/j.pec.2011.05.028).
  •   Glattacker, M Heyduck K, Meffert C (2009). Entwicklung eines Fragebogens zur Erfassung des subjektiven Behandlungskonzepts von Rehabilitanden. Rehabilitation, 48, 345-353.
  •   Glattacker, Heyduck, Meffert: Entwicklung, Implementierung und Umsetzung einer Intervention zur bedarfsgerechten Patienteninformation für Rehabilitandinnen und Rehabilitanden. Rehabilitation, 2010, 49, 292 – 300
  •   Heyduck K, Glattacker M, Meffert C: Rehabilitation aus Patientensicht - Eine qualitative Analyse der subjektiven Behandlungskonzepte von Patienten in der stationären orthopädischen und psychosomatischen Rehabilitation Rehabilitation, 2011; 50 (4): 232-243
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.