|- candidate number||12323|
|- NTR Number||NTR3421|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-mei-2012|
|- Secondary IDs||12-4-033 METC MUMC|
|- Public Title||Adem de Baas.|
|- Scientific Title||The effect of a computer-tailored feedback program on smoking behavior and physical activity of people at risk for or with Chronic Obstructive Pulmonary Disease.|
|- hypothesis||We hypothesize that more participants in the experimental condition, who are offered the computer-tailored feedback program, will quit smoking and that these participants will become more physically active compared to the participants in the control condition, who do not receive the computer-tailored feedback program. Besides, we hypothesize that the experimental condition will obtain better disease related quality of life, level of disability, stage of change and intention to change behavior, compared to the control condition. |
|- Healt Condition(s) or Problem(s) studied||Chronic Obstructive Pulmonary Disease (COPD)|
|- Inclusion criteria||Respondents who have access to the internet, between 40 and 70 years old are included if they have COPD or are classified as having a moderate or high risk of having COPD, according to the RHSQ. Only one respondent per address will be invited.|
|- Exclusion criteria||Respondents are excluded if they are not able to understand Dutch sufficiently.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||21-mei-2012|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||890|
|- Interventions||the intervention is a computer-tailored feedback program, which provides participants with individualized feedback aiming at health related behavior change. By tailoring feedback messages to a personís responses, messages become more personalized and matched to key theoretical determinants of the behavior and characteristics of the person. The program is based on the I-change model, which incorporates several behavioral change theories. For example, the program provides feedback on the reported behavior, participants' attitude, social influence, goals, plans and self-efficacy. The program will be available for all participants in the experimental condition for 6 months. Participants can log in to the program whenever they want and as often as they like. After 6 months the control condition will have access to the program. |
|- Primary outcome||1. Smoking cessation (measurement: questions assessing 7 day point prevalence abstinence, prolonged and continuous abstinence, number of quit attempts, number of cigarettes smoked);|
2. Physical activity (measurement: IPAQ, short version).
|- Secondary outcome||1. Intention to change behaviour (measurement: Questions assessing intention to increase physical activity and quit smoking on a likert scale);|
2. Stage of change (measurement: Questions assessing stage of change for physical activity and smoking, based on prochaska);
3. Disease related quality of life (measurement: Clinical COPD Questionnaire, CCQ);
4. Level of disability (Measurement: Medical Research Counsil scale, MRC);
5. Satisfaction with the intervention (measurement: 9 questions assessing the satisfaction with the intervention;
6. System use (measurement: recorded by the program software).
|- Timepoints||1. Baseline;|
2. 6 months.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| H. Tange|
|- CONTACT for SCIENTIFIC QUERIES|| H. Tange|
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Chronic Obstructive Pulmonary Disease (COPD) is one of the major causes of morbidity and mortality worldwide. Although COPD is a chronic disease, health-related quality of life can be improved and hospitalization can be reduced, by obtaining a healthy lifestyle. A computer-tailored feedback program could help people with COPD or at risk for COPD to improve their health related behavior. The aim of this project is to test the effect of an internet-based lifestyle program providing computer-tailored feedback, on the health behavior of people at risk for or with COPD.
To test the effect of the program on health behavior, aiming at smoking behavior and physical activity. Furthermore, we examine the effect of the program on intention to change behaviour, stages of change, disease related quality of life and level of disability.
The study will be a two armed randomized controlled trial.
People who have a moderate or high risk of having COPD or are diagnosed with COPD.
A computer-tailored feedback program that provides participants of personalized advice to change their behavior.
Main study parameters/endpoints:
1. Smoking cessation;
2. Physical activity.
|- Main changes (audit trail)||07-Jan-2013: Enddate changed from 01-Mar-2013 to 01-Jul-2013 due to an expanded inclusionperiod - NM|
|- RECORD||2-mei-2012 - 7-jan-2013|