Patterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment - The REDUQ II study

Patterns and processes of cognitive and behavioural changes in patients with COPD receiving smoking reduction treatment - The REDUQ II study - REDUQ II study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41681

Enrollment

Registered

2013-09-17

Start date

2013-11-25

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nicotineafhankelijkheid/ tabaksverslaving/rookverslaving COPD (smoker's lung) tobacco addiction

Interventions

Participants of the REDUQ II receive the intervention offered in the REDUQ study. The intervention has been described in detail in the REDUQ study protocol (P09-22/NL30620.044.09) In brief: patients

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Clinical diagnosis of COPD (GOLD criteria stage I-IV); Currently smoking 10 or more cigarettes per day; Age between 40 and 80 years; Two or more failed lifetime quit attempts (abstinentie > 24 hours); Motivated to reduce the number of cigarettes smoked.

Exclusion criteria

Exclusion criteria: Motivated to quit smoking 1 month from baseline (= ready to quit); Not able to speak, read and write Dutch; Contra-indication for the use of all forms of Nicotine Replacement Therapy (NRT); Serious psychiatric morbidity (not only depressive symptoms); Pregnancy.

Design outcomes

Primary

Measure	Time frame
The main study parameter of the RCT is continuous abstinence (cotinine validated) after 18 months, for at least the last full year (also see REDUQ protocol P09-22) The main study parameters of the SCED are factors addressed in the smoking reduction intervention: smoking behaviour (change) and (psychological) factors thought to be predictive of behaviour change. The study parameters are (changes in): • Smoking status • Motivation/Intention to quit • Self-efficacy • Attitudes towards smoking cessation	—

Measure

Time frame

The main study parameter of the RCT is continuous abstinence (cotinine validated) after 18 months, for at least the last full year (also see REDUQ protocol P09-22) The main study parameters of the SCED are factors addressed in the smoking reduction intervention: smoking behaviour (change) and (psychological) factors thought to be predictive of behaviour change. The study parameters are (changes in): • Smoking status • Motivation/Intention to quit • Self-efficacy • Attitudes towards smoking cessation

—

Secondary

Measure	Time frame
Secondary parameters of the RCT are (also see REDUQ protocol P09-22): - point prevalence abstinence rates - sustained reduced smoking at 6, 12, and 18 monhts - disease specific quality of life - lung function (FEV1) - anxiety and depression - nicotine dependence - exacerbations defined as needing treatment with a course of oral steroids or antibiotocs - use of health care services ( to enable a cost-effectiveness analysis) Secondary parameters of the SCED are: - Social influence - Desire or urge to smoke - Treatment adherence (scheduled reduced smoking) - Use of NRT and/or anti-smoking medication	—

Measure

Time frame

Secondary parameters of the RCT are (also see REDUQ protocol P09-22): - point prevalence abstinence rates - sustained reduced smoking at 6, 12, and 18 monhts - disease specific quality of life - lung function (FEV1) - anxiety and depression - nicotine dependence - exacerbations defined as needing treatment with a course of oral steroids or antibiotocs - use of health care services ( to enable a cost-effectiveness analysis) Secondary parameters of the SCED are: - Social influence - Desire or urge to smoke - Treatment adherence (scheduled reduced smoking) - Use of NRT and/or anti-smoking medication

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)