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NCT Number: NCT00979719

Improvement of a Physically Active Lifestyle

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).

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Key information

Conditions

Pain Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Cardiovascular Diseases Connective Tissue Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Immune System Diseases Joint Diseases Metabolic Diseases Motivation Musculoskeletal Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Osteoarthritis Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Freie Universitaet Berlin

Berlin, State of Berlin, 14195, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intervention Group (IG)

Behavioral

patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

Other names: FaBA

Active Control Group (ACG)

Behavioral

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 names: MoVo

Primary outcomes

  1. physical activity

    Time frame: 18 months

Secondary outcomes

  1. subjective health

    Time frame: 18 months

  2. quality of life

    Time frame: 18 months

  3. rehabilitation satisfaction

    Time frame: 18 months

  4. motivation

    Time frame: 18 months

  5. social-cognitive predictors of behavior (self-efficacy, action control etc.)

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Freie Universität Berlin

Other

Collaborators

  • Deutsche Rentenversicherung

Registry information

Official study title

Improvement of a Physically Active Lifestyle in Orthopedic and Cardiologic Rehabilitation Patients With an Expert System

Acronym: FaBA

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Sep 18, 2009
Registry last updated
Nov 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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