Improvement of a Physically Active Lifestyle

Pain Clinical Trial

— FaBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979719
• Other study ID #: 8011 - 106 - 31/31.91
• Secondary ID: 0421/00-40-64-50
• Status: Completed
• Phase: N/A
• First received: September 17, 2009
• Last updated: November 13, 2012
• Start date: October 2009
• Est. completion date: September 2012

Study information

• Verified date: January 2011
• Source: Freie Universität Berlin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1377
• Est. completion date: September 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Behavior
• Diabetes Mellitus, Type 2
• Heart Diseases
• Motivation
• Osteoarthritis
• Pain
• Rheumatoid Arthritis

Intervention

Behavioral:
• Intervention Group (IG)
patients will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients
• 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.)

Locations

Country	Name	City	State
Germany	Freie Universitaet Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Freie Universität Berlin	Deutsche Rentenversicherung

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity		18 months	Yes
Secondary	subjective health		18 months	Yes
Secondary	quality of life		18 months	Yes
Secondary	rehabilitation satisfaction		18 months	Yes
Secondary	motivation		18 months	Yes
Secondary	social-cognitive predictors of behavior (self-efficacy, action control etc.)		18 months	Yes