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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03849092
Other study ID # 119404
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date July 30, 2020

Study information

Verified date August 2020
Source Glostrup University Hospital, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this intervention is to test if the investigator, by offering a financial incentive to smokers who abstinence from smoking, can:

1. recruit more smokers with low socioeconomic status to municipal smoking cessation programs

2. achieve higher abstinence rates at municipal smoking cessation programs among citizens with low economic status - Rather than by use of campaigns (=usual strategy) informing citizens about their options for support at municipal smoking cessation programs?


Description:

For decades the prevalence of smokers has been declining. However, during the last four years the prevalence is stagnated. All municipalities are offering support to/ and during smoking cessation. Nevertheless, a lot of the municipalities find it very difficult to recruit smokers to their programs - in particular smokers with low socioeconomic status.

Hypothesis: It is assumed that more smokers with low socioeconomic status, which are otherwise very difficult to reach with smoking cessation offerings, will attend in municipal smoking cessation programs if they are offered a financial incentive. It is also assumed that smokers with low socioeconomic status, who have difficulty quitting smoking, will achieve higher smoking cessation rates if they are offered a financial incentive of abstinence from smoking. The target group of this study is therefore smokers with low socioeconomic status (SES).

The study involves 6 intervention municipalities (3 financial incentives municipalities and 3 campaign municipalities), and 6 control municipalities. The investigator conducts matched randomization at municipality level, and matches the municipalities on number of smokers recruited to smoking cessation programs in the previous year (2017).

All 6 intervention municipalities receive 102.000 DKK (16536,43 UDS) which must be used on their intervention. Beside the intervention everything goes on as usual in each municipality. Each municipality is its own control and the change will be analyzed after the intervention. The prevalence of smokers in each municipality is registered as usual by means of the Health Profiles, however not in this study!, which aim not is to measure the number of citizens quitting smoking unaided, but solely aim to focus on the municipals smoking cessation activities.

1. Intervention in the 3 financial incentives municipalities: the municipalities will make simple invitations and advertisements, showing that smokers can achieve a financial incentive of 1200 DKK if they abstinence from smoking.

The period of a smoking cessation program is 7 weeks, and participants will receive a financial incentive as a gift voucher the 4 last meeting days, if validated abstinent from smoking.

2. Intervention in the 3 campaign municipalities: each municipality decides how the campaigns/advertisement should look/be like. The campaign should try to target smokers with low SES, recommending getting support during smoking cessation.

3. Control municipalities: 6 "clean" control municipalities perform their smoking cessation activities as usual and do not receive any financial resources. They do not know that they are control group in a trial.

The investigators measure validated recruitment- and abstinence rates 6 and 12 months after last session.


Recruitment information / eligibility

Status Completed
Enrollment 1934
Est. completion date July 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:smoker. -

Exclusion Criteria: non smoker, vaping of e-cigarettes (only)

-

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Financial incentives
Cessation programs in municipalities will offer a financial incentive of 1200 DKK to smokers who achieve continuous abstinence from smoking when attending a group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included.
Campaigns
Municipalities will design anti-smoking campaigns targeting smokers, recommending to use a municipal free group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included.

Locations

Country Name City State
Denmark Center for Clinical Research and Prevention Frederiksberg

Sponsors (1)

Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment Can we by offering financial incentives or by running a stop-smoking campaign recruit more smokers to municipal smoking cessation programs? 12 months
Primary Smoking cessation rates Can we by offering financial incentives or by running a stop-smoking campaign achieve higher smoking cessation rates at municipal smoking cessation programs? 6 months and 12 months
Secondary Recruitment of smokers with low socioeconomic status Can we by offering financial incentives or by running a stop-smoking campaign recruit more smokers with low socioeconomic status to municipal smoking cessation programs 6 weeks, 6 months and 12 months after quit date
Secondary Smoking cessation rates among citizens with low economic status Can we by offering financial incentives or by running a stop-smoking camaign achieve higher smoking cessation rates at municipal smoking cessation programs among citizens with low economic status? 6 weeks, 6 months and 12 months after quit date
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