Trial document




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  DRKS00000584

Trial Description

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Title

Evaluation of a telephonebased health coaching in chronic diseases.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Since 2007 the health insurance “Kaumännische Krankenkasse Hannover” (KKH-Allianz) provides an individualized telephone based health coaching (HC) for chronically ill patients. The aim of the study is to evaluate the efficacy of the HC. One focus will be the reduction of the time till rehospitalisation. Furthermore the health economic effects of the HC will be evaluated.

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Brief Summary in Scientific Language

Background:
Since 2007 the German health insurance fund KKH-Allianz provides a telephone health coaching (HC) for people with chronic diseases. Using motivational interviewing and collaborative goal setting techniques patients are supported to change risky health behaviours. To date it lacks studies regarding the acceptance and the efficacy of HC in Germany. Therefore a randomized controlled trial (RCT) was conducted to analyse the efficacy of HC and its impact on economic outcomes.

Methods/Design:
Focus of the a four-year randomized controlled trial is the efficacy of HC. Estimated 2.600 insurants are assessed at baseline and three yearly follow-ups. Three groups are compared:
1) participants of the HC, 2) insurants that declined to participate, 3) control group.
Additionally to self-rating questionnaire- and software-data the RCT collects the information with the routine data of the health insurance fund.
The analyses will be conducted following the intention-to-treat as well as the per-protocol principle.

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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

  •   DRKS00000584
  •   2011/03/23
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  •   yes
  •   Approved
  •   PV3567, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   I20 -  Angina pectoris
  •   I21 -  Acute myocardial infarction
  •   I22 -  Subsequent myocardial infarction
  •   I23 -  Certain current complications following acute myocardial infarction
  •   I24 -  Other acute ischaemic heart diseases
  •   I25 -  Chronic ischaemic heart disease
  •   I11 -  Hypertensive heart disease
  •   I50 -  Heart failure
  •   E10 -  Insulin-dependent diabetes mellitus
  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   E12 -  Malnutrition-related diabetes mellitus
  •   E13 -  Other specified diabetes mellitus
  •   E14 -  Unspecified diabetes mellitus
  •   J44 -  Other chronic obstructive pulmonary disease
  •   J45 -  Asthma
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Interventions/Observational Groups

  •   A telephone health coaching is braught to chronically ill often multi morbid insurants. It is individually fitted for the needs and the extent of information. 19 health coaches in two supply centers in Halle (Saale) and Munich provide the coaching. The coaches are examined nurses that were especially trained for health coaching. Goal of the health coaching is to empower patients to change risky health behaviors through Motivational Interviewing, goal setting strategies and evidence based information.
  •   treatment as usual:
    Those insurants declined taking part in the telephone health coaching. They are receiving no health coaching. They are responsible to search for information regarding the selfmanagement of their chronic disease.
  •   Control Group:
    Those insurants were not offered to take part in the telephone health coaching. They are receiving no health coaching. They are responsible to search for information regarding the selfmanagement of their chronic disease.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   No treatment
  •   Supportive care
  •   Crossover
  •   N/A
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Primary Outcome

The primary outcome is the time till rehospitalisation. It will be assessed in days through the routine data of the health insurance.

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Secondary Outcome

rehospitalisation rate assessed throuh routine data;
mortality rate assessed throuh routine data;
life quality assessed throuh questionnaire (SF-12);
cost effectiveness assessed throuh routine data;
behavior change assessed throuh questionnaire (stages of change);
health care utilization (doctor visits, drug use, disability) assessed throuh routine data;
reduction of risk factors and risky health behaviors (exercise, nutrition, smoking, alcohol) assessed throuh questionnaire (alcohol: AUDIT, exercise: Freiburger Fragebogen zur körperlichehn Aktivität, questionnaire for smoking behavior, Stages of Change);
drug and therapy adherence assessed throuh questionnaire (MARS);
utilization of other services assessed throuh routine data;
clinical parameters assessed throuh questionnaire;
health economic analyses assessed throuh routine data

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/03/07
  •   2600
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

For the HC invited insured chonically ill people with hospital stay in the last 4-6 weeks (COPD, Asthma, Coronary Heart Disease, Diabetes, Hypertension, Cardiac Insufficiency).

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Exclusion Criteria

Insured people staying in hospital.

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Addresses

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    • Universitätsklinikum Hamburg-Eppendorf Institut und Poliklinik für Medizinische Psychologie
    • Mr.  Prof. Dr. Dr.  Martin  Härter 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf Institut und Poliklinik für Medizinische Psychologie
    • Mr.  Prof. Dr. Dr.  Martin  Härter 
    • Martinistr. 52; W26
    • 20246  Hamburg
    • Germany
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    • Universitätsklinikum Hamburg-Eppendorf Institut und Poliklinik für Medizinische Psychologie
    • Ms.  Sarah  Dwinger 
    • Martinistr. 52; W26
    • 20246  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • KKH-Allianz
    • Mr.  Dr.  Lutz  Herbarth 
    • Karl-Wiechert-Allee 61
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.