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临床试验/NCT00979719
NCT00979719已完成不适用

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

Freie Universität Berlin2 个研究点 分布在 1 个国家目标入组 1,377 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,377
试验地点
2
主要终点
physical activity

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • the participant not be of age
  • severe cognitive deficits
  • visual impairments (patients have to read at the PC)

结局指标

主要结局

physical activity

时间窗: 18 months

次要结局

  • motivation(18 months)
  • subjective health(18 months)
  • quality of life(18 months)
  • rehabilitation satisfaction(18 months)
  • social-cognitive predictors of behavior (self-efficacy, action control etc.)(18 months)

研究者

申办方类型
Other

研究点 (2)

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