Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00004887

Trial Description

start of 1:1-Block title

Title

Changing lifestyle and improving subjective judgment of occupation by a planning-competence-training with follow-up care among type II diabetes mellitus and adiposity inpatients: a randomized controlled trail.

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

Trial Acronym

PKT

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

Observations of patients with type II diabetes mellitus and adiposity having difficulties in transferring the learnt strategies to their daily life after a hospital stay are made.
A strategy-skills-training is meant to train overall abilities which can support the patients in changing their lifestyle and in being more optimistic to return to their jobs.
Accordingly the purpose of the issue is to recognize if a planning-competence-training, additional to the treatment as usual in the clinic, helps the patients in changing their lifestyle concerning dietary and exercise habits and daily schedule. As well the question is raised if they judge their own possibilities to return to their jobs better than before.
Participants to the study are patients with diagnosis type II diabetes mellitus and / or adiposity staying at the clinic Niederrhein during the length of the study.
For answering the issue of the study the patients are disposed to different groups by coincidence. One group receives the planning-competence-training with follow-up care, the second group receives the planning-competence training without follow-up care, the third group receives lectures about health topics with a shorter follow-up care and the last group receives the treatment as usual preserved in the clinic.

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

Brief Summary in Scientific Language

Observations of the clinical daily grind point to the difficulties patients with type II diabetes mellitus and adiposity have with translating the clinically induced changes in lifestyle to their daily lives consistently.
Missing strategies or self-control measures cause an insufficiently transfer of the learned strategies to daily life (cf. Kulzer, Krichbaum & Hermann, 2008).
The planning-competence training is applied to teach skills which allude to concrete planning skills as well as to the ability to analyze problems in addition to the disease- related skills belonging to the TAU.
The keynote of the study is teaching overarching skills by planning-comeptence training.
Against this background the training of planning-competence is meant to alleviate changing lifestyle as change of dietary and exercise habits, return to work chances and therefore improve quality of life.
The issue is approached by a randomized controlled trial (RCT). Planning-competence training and a telephone follow-up care lasting for six months is transmitted in the experimental condition. For controlling the side- effects three control groups are provided. Planning-comptence training without follow-up care is preserved to control group 1. As a placebo condition control group 2 sustains lectures about health topics with placebo follow-up care. Treatment as usual (TAU) is installed as control group 3.

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

Organizational Data

  •   DRKS00004887
  •   2013/10/07
  •   [---]*
  •   yes
  •   Approved
  •   837.567.12 (8668), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   E11 -  Non-insulin-dependent diabetes mellitus
  •   E66 -  Obesity
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Experimental condition: Planning-Competence training with follow-up care.

    The planning competence training is composed of four training units (length 1 -1,5 h) and a transfer session.
    Following three training units the transfer session is placed before the last training unit, which is a parallel construct to the first unit thus functioning as a performance control.
    By providing an opportunity for reflection of the training contents the transfer session supports the process of implementing the content to daily life (length 1,5 h). The units take place at five sequenced days. The individual target planning
    During an one-on-one closing interview(length: about one hour) at the end of the rehabilitation process at the clinic certain goals and plans are defined individually. Each patient formulates individual self-instructions helping to put the plans concnering lifestyle shift into practice. The telephone follow-up care lasts six months in which the patient is called every four weeks. Throughout those phone calls the planned goals and lifestyle shifts are discussed (length about 15 minutes).
  •   Control group 1: Planning-Competence training without follow-up care
  •   Control group 2: Placebocondition with placebo follow-up care
    The placebo- intervention serves lectures about general topics in health care and prevention like stressprevention, relaxation, alcohol, burnout prevention and salutogenisis (length about 30 minutes). In addition the contact is abided by one-on-one interviews in the end of the training and a placebo telephone follow-up care (each telephone call lasting about 15 minutes). General state of health is addressed during those calls without bringing up the topics of lifestyle shift.


  •   Control group 3: Normal treatment (without planning-competence training or follow-up care)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Placebo, Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Return to work prediction: „Skala der subjektiven Prognose der Erwerbstätigkeit“ (SPE-Skala), Mittag & Raspe (2003);
Measured at the beginning of the rehabilitation (t1), at the end (t2) and six months after the rehabilitation

daily routine (dietary and exercise habits):
dietary habits: „Fragebogen zum Ernährungsverhalten“
Measured at the beginning of the rehabilitation (t1) and six months after the rehabilitation (t3)

exercise habits: metabolic equivalent
Measured at the beginning of the rehabilitation (t1), at the end (t2) and six months after the rehabilitation (t3)

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

Secondary Outcome

Rehabilitational anticipations, motivational aspects
and quality of life: FREM-8 (Deck, 2006); „Patientenfragebogen zur Erfassung der Reha-Motivation“ (PAREMO-20, Nübling, Kriz, Herwig, Wirtz, Töns & Bengel, 2005)
Measured at the beginning of the rehabilitation (t1) and six months after the rehabilitation (t3).

„Patient Health questionnaire“ (PHQ-2, Kroenke, Spitzer, Williams, 2003);
Measured at the beginning of the rehabilitation (t1), at the end (t2) and six months after the rehabilitation (t3).

Self-efficacy expectancy: „Skala zur allgemeinen Selbstwirksamkeitserwartung“ , Jerusalem und Schwarzer (2012), „Skala zur Erfassung der beruflichen Selbstwirksamkeit“ , Abele, Stief und Andrä (2000);
Measured at the beginning of the rehabilitation (t1), at the end (t2) and six months after the rehabilitation

Body-mass-index: removed out of the health report or self-report at t3.
Measured at the beginning of the rehabilitation (t1), at the end (t2) and six months after the rehabilitation

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

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/01/16
  •   791
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients of the clinic Niederrhein diagnosed Diabetes mellitus Typ II or /and adipositas

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

Exclusion Criteria

Pension

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • REFONET
    • Mr.  Burkhard  Wild 
    • 53445  Bad Neuenahr- Ahrweiler
    • 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
    • Institut für Psychologie RWTH Aachen, Lehr- & Forschungsgebiet Berufliche Rehabilitation
    • Ms.  PD Dr. phil.  Viktoria  Arling 
    • Jägerstr. 17-19
    • 52066  Aachen
    • 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
    • Klinik Niederrhein
    • Ms.  -  Frauke  Huth 
    • Hochstraße 21
    • 53445  Bad Neuenahr-Ahrweiler
    • 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
    • REFONET
    • 53445  Bad Neuenahr- Ahrweiler
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   02641 9062-0
    •   [---]*
    •   [---]*
    •   [---]*
    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
  •   2015/04/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.