Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003213

Trial Description

start of 1:1-Block title

Title

Communication competencies of chronically ill patients in interaction with providers

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

Trial Acronym

KoKoPa

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

Several studies support the notion that intact patient provider communication is linked to higher adherence and partly connected to better treatment outcome. Caregiver’s communication skills have been thoroughly researched, whilst very few studies have investigated the effective elements of communications skills (e.g. posing inquiring, describing medical condition, expressing concerns) in chronically ill patients (e.g. chronic back pain or breast cancer) . This is the case despite the fact that international interventions studies have found that effective communication promotes empowerment in chronically ill patients. This project investigates whether patients’ competent communication behaviour is related to desirable outcome variables in patient caregiver communication (e.g. higher satisfaction and adherence, better health condition) and if this effect is influenced by gender. For that purpose several qualitative pilot studies (interviews, interaction analyses) will be executed. Furthermore, questionnaires are developed and psychometrically tested that assess patients’ communication preferences. Finally, a patient communication training (including a manual) will be developed.

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

Brief Summary in Scientific Language

By employing an empowerment approach individual capabilities should be strengthened and societal conditions, which enable the patient to live a self-dependent and self-determined, will be supported. Applied to the patient caregiver context this means that communication training should not solely aim at the caregiver but also relate to patients. This should enable them to exert a sensible amount of control over patient caregiver communication. This approach is supported by empirical findings that show that the use of relatively easy realizable patient communication trainings can increase participation. On the other hand, it has been demonstrated that caregiver trainings has a quite minor and inconsistent effects, whilst the realization of these trainings was comparatively laborious. In relation to that studies show that patients’ particular communication behaviours have a positive influence on how doctors convey information. Hence, the patient can influence the caregivers’ behaviour. Fostering patients’ communication competencies (e.g. asking questions, verifying information, expressing concerns, artuiculate preferences) during patient caregiver interaction can be regarded as important area of patient skills and portrays a concrete demand for interventions to increase health literacy (health concept).

During the KoKoPa project different models of patient caregiver communication are applied based on which theoretical selection of the investigated variables takes place and competent communication behaviour is determined. The project tries incorporate current requirements for performing innovative research in the area of patient-caregiver communication a) a consistent relation to theory b) the incorporation of health as a long-term outcome c) the integration of qualitative and quantitative methods as well as self-report and the analysis of interaction d) the consideration of patients’ communication preferences and e) the conceptualisation of integrated training for patient and caregiver.
Specifically the aim is to achieve the following goals: To question patients and caregivers about their communication behaviours with chronically ill patients (qualitative study 1). This study aims to understand attitudes and subjective concepts that are important to incorporate for execution of this study and for the conceptualization of the intervention. This is followed by a qualitative study that employs interaction and sequence methods in order to analyse the effect of patient caregiver interaction on patient behaviour (Qualitative Study 2). Effective behaviours are identified (immediate reactions of the caregiver; patient satisfaction) using the short-term outcomes of the qualitative study 1 and 2. Simultaneously, the content (including background from the literature) is used to two develop communication skills questionnaires (self and third party evaluation). The final qualitative study 3 includes a cognitive pre-test of patient questionnaires that have been developed in this study. During the first quantitative study the psychometric characteristics are assessed. In the second quantitative study central questions will be investigated: Will the hypotheses concerning effective (and maybe competent) patient behaviours be confirmed? How competent will chronic patients behave? What influence will the sex have on this behaviour? The final stage of the project will consist of modules to train patients. Simultaneously, focus groups will be run in order to tailor the content of the trainings towards chronically ill patients. Patients with chronic back pain, chronic ischemic heart disease and breast cancer will be investigated during individual studies of the project.

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

Organizational Data

  •   DRKS00003213
  •   2011/08/10
  •   [---]*
  •   yes
  •   Approved
  •   149/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1123-2101 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Chronic back pain
  •   Chronic ischemic heart disease
  •   breast cancer
  •   M47.1 -  Other spondylosis with myelopathy
  •   M47.2 -  Other spondylosis with radiculopathy
  •   M47.8 -  Other spondylosis
  •   M47.9 -  Spondylosis, unspecified
  •   M48.1 -  Ankylosing hyperostosis [Forestier]
  •   M48.2 -  Kissing spine
  •   M48.8 -  Other specified spondylopathies
  •   M48.9 -  Spondylopathy, unspecified
  •   M51.0 -  Lumbar and other intervertebral disc disorders with myelopathy
  •   M51.1 -  Lumbar and other intervertebral disc disorders with radiculopathy
  •   M51.2 -  Other specified intervertebral disc displacement
  •   M51.3 -  Other specified intervertebral disc degeneration
  •   M51.4 -  Schmorl's nodes
  •   M51.8 -  Other specified intervertebral disc disorders
  •   M51.9 -  Intervertebral disc disorder, unspecified
  •   M53.8 -  Other specified dorsopathies
  •   M53.9 -  Dorsopathy, unspecified
  •   M54.1 -  Radiculopathy
  •   M54.3 -  Sciatica
  •   M54.4 -  Lumbago with sciatica
  •   M54.5 -  Low back pain
  •   M54.8 -  Other dorsalgia
  •   M54.9 -  Dorsalgia, unspecified
  •   M45.4 - Persistent somatoform pain disorder
  •   I25 -  Chronic ischaemic heart disease
  •   C50 -  Malignant neoplasm of breast
  •   C50.0 -  Malignant neoplasm: Nipple and areola
  •   C50.1 -  Malignant neoplasm: Central portion of breast
  •   C50.2 -  Malignant neoplasm: Upper-inner quadrant of breast
  •   C50.3 -  Malignant neoplasm: Lower-inner quadrant of breast
  •   C50.4 -  Malignant neoplasm: Upper-outer quadrant of breast
  •   C50.5 -  Malignant neoplasm: Lower-outer quadrant of breast
  •   C50.6 -  Malignant neoplasm: Axillary tail of breast
  •   C50.8 -  Malignant neoplasm: Overlapping lesion of breast
  •   C50.9 -  Malignant neoplasm: Breast, unspecified
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The KoKoPa-project consists of five partial studies, three pre-studies and two main studies. We include one group of participants (chronically ill patients = chronic back pain, chronic ischemic heart disease or breast cancer).
    The aim of the pre-studies is to develop items for questionnaires (to measure communication competencies of chronically ill patients). These questionnaires will be psychometrically tested in main study one, and in main study two we will analyse communication competences and survey their impact on relevant outcome variables.

end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary Outcome of the project is to develop two communication skills questionnaires (self [KoKoPA and KoKoPE questionnaires] and third party evaluation [KoKoBE questionnaire]).

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

Secondary Outcome

Secondary Outcome is the quantitative analysis of impact of communication competencies on positive outcomes of patient-provider-communication.

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
  •   2011/07/05
  •   950
  •   Monocenter 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

Fulfulling diagnosis "Chronic back pain", "Chronic ischemic heart disease" or "Breast cancer"

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

Exclusion Criteria

Language impairment, cognitive and/or physical impairment (patient is not able to fill out questionnaire).

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg; Abteilung für Qualitätsmanagement und Sozialmedizin (AQMS)
    • Engelbergerstraße 21
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0761-27074470
    •   0761-27073310
    •   [---]*
    •   http://www.aqms.de
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg; Abteilung für Qualitätsmanagement und Sozialmedizin (AQMS)
    • Mr.  Prof. Dr.  Erik  Farin-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
    • Universitätsklinikum Freiburg; Abteilung für Qualitätsmanagemnet und Sozialmedizin (AQMS)
    • Ms.  Dipl.-Psych.  Erika  Schmidt 
    • 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
    • BMBF
    • Ms. 
    • Heinemannstr. 2
    • 53175  Bonn
    • 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 ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Gustke, M., Gramm, L., Schmidt, E., Farin, E. (2012): Kompetentes Kommunikationsverhalten chronisch Kranker in der Arzt-Patient-Interaktion – Ergebnisse einer Befragung zu subjektiven Konzepten von Patienten. Abstract. DRV-Schriften, 2012; 98: 129-131 (21. Rehabilitationswissenschaftliches Kolloquium/ 05.-07.3.2011 in Hamburg/ DRV Bund und DRV Nord), Deutsche Rentenversicherung Bund (Hrsg) [Vortrag]
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.