Condition category
Mental and Behavioural Disorders
Date applied
10/08/2006
Date assigned
04/01/2007
Last edited
04/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.refonet.de/projekte/laufendeprojekte_3014.php

Contact information

Type

Scientific

Primary contact

Dr Jörg Resler

ORCID ID

Contact details

Bubertstr.4
Borkum
26757
Germany
+49 (0) 4922/9212000
joerg.resler@nordseeklinik-borkum.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

ESMOREHA

Study hypothesis

1. Patients who complete intensive follow-up programs more frequently quit or reduce their smoking than those without such an intervention.
2. The smoking cessation program in Borkum is at least as successful as comparable programs.
3. The quit date method leads to a higher long-therm outcome relative to nicotine abstinence.

Ethics approval

Ethics Committee of the Medical Association of Lower Saxony Germany, approval received on the 22nd September 2005.

Study design

Monocentric, prospective, randomised controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Smoking addiction

Intervention

Follow-up reminder calls and refresher courses for 12 months versus care as usual.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Reduction of the risk of nicotine-associated illness.

Secondary outcome measures

1. Quality of life improvement
2. Reduction in direct and indirect costs

Overall trial start date

01/07/2006

Overall trial end date

31/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients of the Nordseeklinik
2. Funded by the Deutsche Rentenversicherung Rheinland
3. Patients who are older than 18

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

580

Participant exclusion criteria

1. Patients who are younger than 18
2. Linguistic or intellectual deficits
3. Missing agreement

Recruitment start date

01/07/2006

Recruitment end date

31/05/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Bubertstr.4
Borkum
26757
Germany

Sponsor information

Organisation

Refonet (Germany)

Sponsor details

Burgweg 3
Bad Neuenahr-Ahrweiler
53445
Germany
+49 (0) 264 190620
service@refonet.de

Sponsor type

Industry

Website

http://www.refonet.de

Funders

Funder type

Industry

Funder name

Refonet (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes