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REU-stop - Effect of Intensive Smoking Cessation Intervention on Smoking Cessation and Disease Activity in Patients With Rheumatoid Arthritis.

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ClinicalTrials.gov Identifier: NCT02901886
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
The Danish Rheumatism Association
The Novo Nordic Foundation
Region Capital Denmark
TrygFonden, Denmark
Information provided by (Responsible Party):
Bente Appel Esbensen, Glostrup University Hospital, Copenhagen

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Behavioral: Intensive smoking cessation intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: REU-stop - Effect of Intensive Smoking Cessation Intervention on Smoking Cessation and Disease Activity in Patients With Rheumatoid Arthritis.
Study Start Date : October 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intensive smoking cessation intervention

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

No Intervention: Control
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.



Primary Outcome Measures :
  1. Self-reported continuous smoking cessation validated by exhaled carbon-monoxide at 3 months follow-up [ Time Frame: 3 months post-intervention ]
    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

  2. EULAR clinical response (an improvement in DAS28 of >0.6) at 3 months follow-up [ Time Frame: 3 months post-intervention ]
    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


Secondary Outcome Measures :
  1. Self-reported smoking status at 6 and 12 months post-intervention [ Time Frame: 6 and 12 months post-intervention ]
    Smoking status will be monitored by self-reported continuous smoking cessation and biochemically validated by exhaled CO. Continuous smoking cessation will be measured by asking the patients who reports 7-day point prevalence (7 day time-line follow back) how many days they have not been smoking. Smoking status information is self-reported by the participant and documented in the smoking diary at 3 months post intervention (week 18). To be grouped as having "stopped smoking" both self-reported and biochemical analysis should indicate this.

  2. EULAR repsonse at 6 and 12 months post-intervention [ Time Frame: 6 and 12 months post-intervention ]
    Disease activity will be registered by DAS28, as described above in primary outcome.

  3. Disease activity measured by DAS28 at 3, 6 and 12 months post-intervention [ Time Frame: 3, 6 and 12 months post-intervention ]
    DAS28 as described above.

  4. Change in number of swollen and tender joints at 3, 6 and 12 months post-intervention [ Time Frame: 3, 6 an 12 months post-intervention ]
    Assessed by a person blinded to the intervention

  5. Physician and patient Global VAS [ Time Frame: 3, 6 and 12 months post-intervention ]
    Assessed by a person blinded to the intervention

  6. C-reactive protein (CRP) [ Time Frame: 3, 6 and 12 months post-intervention ]
    Measured using blood sample.

  7. Patient assessed disease activity by the FLARE Instrument [ Time Frame: 3, 6 and 12 months post-intervention ]
    Participants will be asked to answer the FLARE instrument (FI), which is a patient self-assessment questionnaire for detecting changes in disease activity among patients with RA. It is designed to detect both past and present disease activity. The questionnaire consists of 12 questions answered on a Likert scale (0 = completely agree, 10 = completely disagree). Higher scores indicate flare. A score > 2.5 indicates a flare.

  8. Blood pressure and pulse [ Time Frame: 3, 6 and 12 months post-intervention ]
    • Blood pressure (mmHg) and heart rate (beats/min) will be measured after 5 minutes of rest (supine position) (Mobil-O-Graph, IEM; Germany). If it exceeds 140/90 mmHg, two additional measurements will be performed and the mean of the last two will be registered.

  9. Arterial stiffness [ Time Frame: 3, 6 and 12 months post-intervention ]
    • Arterial stiffness will be measured by pulse wave velocity (PWV) (Mobil-O-Graph, IEM; Germany). High PWV is defined as > 9.9 m/s

  10. Serum lipids [ Time Frame: 3, 6 and 12 months post-intervention ]
    Serum lipids (TC, HDL-c, LDL-c and TG) will be measured in venous blood samples.

  11. HbA1c [ Time Frame: 3, 6 and 12 months post-intervention ]
    Will be measured using blood sample.

  12. Waist circumference [ Time Frame: 3, 6 and 12 months post-intervention ]
    • Waist circumference will be evaluated by a tape measure in centimetres (cm) while the patient is standing. For women with a waist circumference >80 cm there is an increased risk of CVD while the risk is further increased for waist circumference >88 cm. For men the measures are defined as >94 cm and >102 cm, for increased, and further increased, risk of CVD, respectively.

  13. Body weight [ Time Frame: 3, 6 and 12 months post-intervention ]
    • Body weight will be measured to the nearest 0.1 kg (with ordinary clothes, but without shoes) (OBH Nordica, Slim Light, 150 kg, Taastrup Denmark).

  14. Lung function [ Time Frame: 3, 6 and 12 months post-intervention ]
    FEV1 will be measured by spirometer (EasyOneTM, Model 2001 diagnostic Spirometer, Model 2010 Cradle, NDD Medizintechnik AG; Switzerland).

  15. Physical function [ Time Frame: 3, 6 and 12 months post-intervention ]
    HAQ is a standardized questionnaire for assessing disability and physical function in patients with RA. The instrument contains 20 items with four possible answers in eight categories; dressing, rising from a seat, eating, walking, personal hygiene, stretching for an object, grabbing an object and everyday activities. The questionnaire also includes VAS scales for pain, fatigue and general health. In DANBIO five additional questions have been added. They also have four possible answers and relate to physical function, sleep, anxiety and depression. In this study we will use the 25 questions as used in DANBIO.

  16. Health-related quality of life [ Time Frame: 3, 6 and 12 months post-intervention ]

    HR-QoL is measured using the following two questionnaires:

    1. SF-36 is a generic instrument measuring HR-QoL by 36 items on eight scales. The scales are; physical function, physical activity, limitations, pain, general health, vitality, social function, emotional activity limitations and mental health; they are summarized in two summary scales; 1) the physical component scale (PCS) and 2) the mental component scale (MCS).
    2. The questionnaire contains five items (movement, personal care, usual activities, pain and anxiety/depression) each with five possible ratings.

  17. Pain Pain [ Time Frame: 3, 6 and 12 months post-intervention ]
    Pain related to RA is self-reported by participants using the VAS. Participants rate their subjectively experienced level of pain from 0-10. Zero represents "no pain" and 10 represent the "worst imaginable pain". The scale is included in HAQ.

  18. Fatigue [ Time Frame: 3, 6 and 12 months post-intervention ]
    The BRAF-NRS assesses fatigue in patients with RA. It includes three questions concerning fatigue (level, effect and coping) over the previous seven days. Participants rate fatigue on a scale from 0-10 . Zero represent "no fatigue" and 10 represent the "worst fatigue".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria Patients will be included in the study if they have RA as defined by the American College of Rheumatology (ACR) 1987 criteria and/or European League Against Rheumatism (EULAR) 2010 criteria (32, 33), >18 years of age, smoking tobacco daily, are able to understand and speak Danish or Norwegian, respectively. Furthermore, patients need to for the past three months to have been in clinical remission or low-moderate disease activity (DAS28 ≤ 5.1) and in stable anti-rheumatic medical treatment as documented in 1) the DANBIO registry in Denmark, or 2) the electronic patient journal, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.

Exclusion criteria Patients will be excluded from the study if they have had a change of dose or preparation in anti-rheumatic medical treatment within the previous 3 months, or a scheduled change in anti-rheumatic medical treatment, including glucocorticoid injection during the previous month, are cognitively or otherwise unable to give informed consent, are pregnant or breastfeeding.

Excluded patients, and eligible patients who do not want to participate, will be registered in one of the following three categories 1) not meeting the inclusion criteria 2) refused to participate 3) other reasons.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901886


Contacts
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Contact: Ida Kristiane Roelsgaard, RN, PhD student + 45 3863 4 49 ida.kristiane.roelsgaard@regionh.dk
Contact: Bente Appel Esbensen, PhD, RN +45 38634056 bente.appel.esbensen@regionh.dk

Locations
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Denmark
Center for Rheumatology and Spine Diseases, Rigshospitalet Recruiting
Glostrup, Denmark, 2600
Contact: Ida Roelsgaard, PhD student    + 45 3863 44 49    ida.kristiane.roelsgaard@regionh.dk   
Norway
Preventive Cardio-Reuma Clinic, Diakonhjemmet Recruiting
Oslo, Norway
Contact: Anne Grete Semb       A-SEMB@DIAKONSYK.NO   
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
The Danish Rheumatism Association
The Novo Nordic Foundation
Region Capital Denmark
TrygFonden, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bente Appel Esbensen, Senior Researcher, Associate professor, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT02901886     History of Changes
Other Study ID Numbers: H-16022001
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bente Appel Esbensen, Glostrup University Hospital, Copenhagen:
Rheumatoid Arthritis
Smoking Cessation
Disease Activity
Clinical Prevention
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action