Improvement of a Physically Active Lifestyle (FaBA)
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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 |
- physical activity [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- 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 |
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| Germany | |
| Freie Universitaet Berlin | |
| Berlin, Germany, 14195 | |
| 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 May 16, 2013