Improvement of a Physically Active Lifestyle (FaBA)

This study has been completed.
Sponsor:
Collaborator:
Deutsche Rentenversicherung Bund (DRV; German Retirement Insurance)
Information provided by:
Freie Universität Berlin
ClinicalTrials.gov Identifier:
NCT00979719
First received: September 17, 2009
Last updated: November 13, 2012
Last verified: January 2011
  Purpose

To help rehabilitation patients to adopt and maintain a physically active lifestyle, it is imperative to increase self-management competencies. Aim of this research project is to evaluate an evidence- and theory-based computerized expert system in comparison to a well established standard program and a questionnaire-only group. Rehabilitation patients will be treated psychologically and followed up over 18 months. The computerized expert system is expected to help patients better than the standard program. Both interventions are hypothesized to improve self-management competencies over and above the rehabilitation treatment (i.e., questionnaire-only group).


Condition Intervention
Pain
Osteoarthritis
Rheumatoid Arthritis
Heart Diseases
Diabetes Mellitus, Type 2
Behavior
Motivation
Behavioral: Intervention Group (IG)
Behavioral: Active Control Group (ACG)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improvement of a Physically Active Lifestyle in Orthopedic and Cardiologic Rehabilitation Patients With an Expert System

Resource links provided by NLM:


Further study details as provided by Freie Universität Berlin:

Primary Outcome Measures:
  • physical activity [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • subjective health [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • rehabilitation satisfaction [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • motivation [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • social-cognitive predictors of behavior (self-efficacy, action control etc.) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 1377
Study Start Date: October 2009
Study Completion Date: September 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Group (IG)
Patients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
Behavioral: Intervention Group (IG)
patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
Other Name: FaBA
Placebo Comparator: Active Control Group (ACG)
Patients in the ACG will get an interactive computerized standard program which has been proven to be effective (Göhner, & Fuchs, 2007) Göhner, W. & Fuchs, R. (2007). Änderung des Gesundheitsverhaltens. MoVo-Gruppenprogramme für körperliche Aktivität und gesunde Ernährung. Göttingen: Hogrefe.
Behavioral: Active Control Group (ACG)
Patients in the ACG will get an interactive computerized standard program which has been proven to be effective (Göhner, W. & Fuchs, R. (2007). Änderung des Gesundheitsverhaltens. MoVo-Gruppenprogramme für körperliche Aktivität und gesunde Ernährung. Göttingen: Hogrefe.)
Other Name: MoVo
No Intervention: Passive Control Group (PCG)
patients are asked to answer the questionnaires only

Detailed Description:

An experimental study with three groups is planned over a time period of 18 months. Patients in the intervention group receive an interactive, computerized expert system (Intervention Group, IG). Patients in the Active Control Group (ACG) get an interactive computerized standard program. This standard program has already been proven to be effective but which does not tailor treatment components to the individual needs of the patients. Patients in the Passive Control Group (PCG) are asked to answer the questionnaires only. Rehabilitation patients (N = 1000) will be recruited in three rehabilitation clinics and followed up over six measurement points: t1 and t2 with computer interventions during their rehabilitation stay; t3 and t4 with booster-sessions via telephone (6 weeks and 6 months after admission from rehabilitation). Furthermore, patients will be contacted at t5 per mail with motivational material (12 months after admission) and at t6 again per mail (only questionnaire, 18 months after admission).

The hypotheses are: In comparison to the PCG, both the IG and the ACG are expected to have a higher motivation, to adopt a healthy lifestyle, to perform more health behavior and to be less likely to relapse into previous unhealthy routines. Also, IG and ACG will be healthier as well as they will report more quality of life and rehabilitation satisfaction. In comparison to ACG, the IG is hypothesized to be more effective than the ACG regarding motivation, behavior and social-cognitive predictors of behavior. Moreover, the interventions (ACG and IG) are supposed to be equally effective for cardiac and orthopedic, as well as out-patient and stationary treated rehabilitation patients. After successful evaluation and some adoptions the intervention will be implemented as a self-help program in all eligible rehabilitation clinics and in the internet.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • to be capable of exercising on their own at the minimum level recommended by the according rehabilitation clinic
  • able to fill out a questionnaire (no illiteracy)
  • adequate German language ability

Exclusion Criteria:

  • the participant not be of age
  • severe cognitive deficits
  • visual impairments (patients have to read at the PC)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979719

Locations
Germany
Freie Universitaet Berlin
Berlin, Germany, 14195
Sponsors and Collaborators
Freie Universität Berlin
Deutsche Rentenversicherung Bund (DRV; German Retirement Insurance)
Investigators
Principal Investigator: Sonia Lippke, PhD Freie Universitaet Berlin
  More Information

No publications provided by Freie Universität Berlin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sonia Lippke, Dr.; Assistant Professor (C1), Freie Universität Berlin
ClinicalTrials.gov Identifier: NCT00979719     History of Changes
Other Study ID Numbers: 8011 - 106 - 31/31.91, 0421/00-40-64-50-00
Study First Received: September 17, 2009
Last Updated: November 13, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Freie Universität Berlin:
Randomized Controlled Trial
evidence- and theory-based behavioral intervention
expert system
stages of change
motivational interviewing
tailoring
Self Care
Rehabilitation
Expert Systems

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014