NCT02901886

Brief Summary

This study aims to test the effect of an intensive smoking cessation intervention (motivational counseling combined with nicotine replacement) on smoking cessation and disease activity in patients with Rheumatoid Arthritis (RA). Half of the patients will participate in a smoking cessation intervention; the other half will receive usual treatment.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

3.5 years

First QC Date

September 10, 2016

Last Update Submit

January 5, 2020

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisSmoking CessationDisease ActivityClinical Prevention

Outcome Measures

Primary Outcomes (2)

  • Self-reported continuous smoking cessation validated by exhaled carbon-monoxide at 3 months follow-up

    The participants' smoking status will be monitored by self-reported continuous smoking cessation validated by exhaled carbon monoxide (CO) in breath (CO-Check, NEOMED GmbH; Germany). Carbon monoxide values \> 10 parts per million (ppm) indicate tobacco smoking

    3 months post-intervention

  • EULAR clinical response (an improvement in DAS28 of >0.6) at 3 months follow-up

    The recommended EULAR clinical response in relation to disease activity will be assessed using DAS28 at 3 months post-intervention. The DAS28 score consists of four elements; CRP, number of swollen joints, number of painful joints (maximum 28) and a Global General Health VAS score. The joint count and Global General Health are assessed by both the participant and a project nurse blinded to group allocation

    3 months post-intervention

Secondary Outcomes (18)

  • Self-reported smoking status at 6 and 12 months post-intervention

    6 and 12 months post-intervention

  • EULAR repsonse at 6 and 12 months post-intervention

    6 and 12 months post-intervention

  • Disease activity measured by DAS28 at 3, 6 and 12 months post-intervention

    3, 6 and 12 months post-intervention

  • Change in number of swollen and tender joints at 3, 6 and 12 months post-intervention

    3, 6 an 12 months post-intervention

  • Physician and patient Global VAS

    3, 6 and 12 months post-intervention

  • +13 more secondary outcomes

Study Arms (2)

Intensive smoking cessation intervention

EXPERIMENTAL

The intervention includes 1) Individual motivational counseling in combination with 2) nicotine replacement therapy. The intervention consists of five individual motivational counselling sessions, each lasting 20 to 40 minutes over a period of six weeks with a trained smoking cessation counsellor. The principles of motivational counselling are based on the trans theoretical model of change. The smoking cessation counsellor has also been trained in motivational counselling techniques specific to this intervention. 2\. Nicotine replacement therapy The participants in the intervention group will be offered nicotine replacement therapy (NRT) free of charge and if accepted it will be tailored individually according to the Fagerström's Test for Nicotine Dependence. The participants will note their tobacco and NRT consumption in a smoking diary.

Behavioral: Intensive smoking cessation intervention

Control

NO INTERVENTION

The control group will receive the standard treatment and care in the rheumatology outpatient clinic. The participants will be encouraged to write a diary describing their tobacco use during the trial period. If participants in the control group express an interest in receiving smoking cessation counselling, they will be informed about municipal programs.

Interventions

Intensive smoking cessation interventionBEHAVIORAL

The intervention includes 1) Individual motivational counseling (5 meetings within 6 weeks) in combination with 2) nicotine replacement therapy.

Intensive smoking cessation intervention

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Rheumatology and Spine Diseases, Rigshospitalet

Glostrup Municipality, 2600, Denmark

Location

Preventive Cardio-Reuma Clinic, Diakonhjemmet

Oslo, Norway

Location

Related Publications (2)

  • Esbensen BA, Thomsen T, Roelsgaard IK, Ostergaard M, Hetland ML, Andersen L, Tonnesen H, Semb AG, Christensen R. Effect of an intensive smoking cessation intervention on smoking cessation and disease activity in patients with rheumatoid arthritis: a randomised controlled trial. Rheumatology (Oxford). 2025 Aug 21:keaf448. doi: 10.1093/rheumatology/keaf448. Online ahead of print.

    PMID: 40839209DERIVED

  • Roelsgaard IK, Thomsen T, Ostergaard M, Christensen R, Hetland ML, Jacobsen S, Andersen L, Tonnesen H, Rollefstad S, Semb AG, Esbensen BA. The effect of an intensive smoking cessation intervention on disease activity in patients with rheumatoid arthritis: study protocol for a randomised controlled trial. Trials. 2017 Nov 28;18(1):570. doi: 10.1186/s13063-017-2309-5.

    PMID: 29183347DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidSmoking Cessation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, Associate professor

Study Record Dates

First Submitted

September 10, 2016

First Posted

September 15, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2020

Study Completion

January 1, 2021

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

NO(1)DK(1)