NCT04772144

Brief Summary

The purpose of this randomized controlled pilot study is to test whether an in-hospital nurse-led smoking cessation intervention increases the refferal rate to healty life-centers in the municipalities. We will also describe the proportion who succeed in quitting smoking between the intervention group and the control group and obtain new knowledge about the patient and system factors of importance for participation to healty life-centers and for successful and unsuccessful smoking cessation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

1.3 years

First QC Date

January 7, 2021

Last Update Submit

October 17, 2022

Conditions

Smoking CessationSmoking BehaviorsNurse's RoleCardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • Differences in participation rate at healthy life-centers between the intervention group and the control group measured by telephone interview with personnell at the healthy life-centers

    Differences in participation rate at healthy life-centers between the intervention group and the control group measured by telephone interview with personnell at the healthy life-centers

    8-12 weeks after randomization

  • Differences in use of smoking cessation aids between the intervention group and the control group

    Differences in use of smoking cessation aids between the intervention group and the control group measued by patient self-report and collected from the prescription mediator in the hospital record

    8-12 weeks after randomization

Secondary Outcomes (2)

  • Difference in point prevalence of smoke-free (no cigarettes last 7 days) after 6 months

    12 weeks after randomization

  • Difference between the groups in proportion who quit smoking between the groups

    12 weeks after randomization

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: behavioural and cessation aids

Control group

NO INTERVENTION

Interventions

behavioural and cessation aidsBEHAVIORAL

information, motivational interview, refferal to healty life-centers, free cessation aids

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\> 18 years and smokes at least 1 cigarette daily
  • Hospitalized with a cardiovascular event (i.e. myocardial infarction, heart failure, unstable or stable angina, achyarrhythmias, bradyarrhythmias, carotid stenosis or claudication with need for peripheral revascularization)
  • Sign informed consent and is expected to participate according to ICH / GCP

You may not qualify if:

  • Does not meet the criteria to participate in the pilot project, i.e. patients who do not usually live or work in the Vestre Viken catchment area
  • Chronic renal failure stage 4 or known allergic reaction to varenicline
  • Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical
  • Lack of Norwegian and English knowledge
  • Short life expectancy (\<12 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drammen Hospital

Drammen, Akershus, 3004, Norway

Location

MeSH Terms

Conditions

Smoking CessationSmokingCardiovascular Diseases

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • John munkhaugen, MD, PhD

    Vestre Viken Trust, Drammen hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: patients were randomized to an in-hospital nurse-led smoking cessation intervention with prescription of free cessation aids and systematic referrral to healthy life-centeres or usual care
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

February 26, 2021

Study Start

February 25, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

October 18, 2022

Record last verified: 2022-10

Locations

NO(1)