Improvement of a Physically Active Lifestyle

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

Sponsors

Lead Sponsor: Freie Universität Berlin

Collaborator: Deutsche Rentenversicherung

Source Freie Universität Berlin
Brief 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).

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.

Overall Status Completed
Start Date October 2009
Completion Date September 2012
Primary Completion Date November 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
physical activity 18 months
Secondary Outcome
Measure Time Frame
subjective health 18 months
quality of life 18 months
rehabilitation satisfaction 18 months
motivation 18 months
social-cognitive predictors of behavior (self-efficacy, action control etc.) 18 months
Enrollment 1377
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Intervention Group (IG)

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

Arm Group Label: Intervention Group (IG)

Other Name: FaBA

Intervention Type: Behavioral

Intervention Name: Active Control Group (ACG)

Description: 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.)

Arm Group Label: Active Control Group (ACG)

Other Name: MoVo

Eligibility

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Sonia Lippke, PhD Principal Investigator Freie Universitaet Berlin
Location
Facility: Freie Universitaet Berlin
Location Countries

Germany

Verification Date

January 2011

Responsible Party

Name Title: Sonia Lippke, Dr.; Assistant Professor (C1)

Organization: Freie Universität Berlin

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Intervention Group (IG)

Type: Experimental

Description: Patients in the IG will receive an interactive, computerized expert system which tailors treatment components to the individual needs of the patients

Label: Active Control Group (ACG)

Type: Placebo Comparator

Description: 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.

Label: Passive Control Group (PCG)

Type: No Intervention

Description: patients are asked to answer the questionnaires only

Acronym FaBA
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov