Biotherapies and Therapeutic Education in Chronic Inflammatory Rheumatism
NCT ID: NCT03838939
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2019-01-21
2021-12-10
Brief Summary
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Detailed Description
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1. Experimental group (individual and group therapeutic education )
* M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".
* M3 (group with 3 to 10 patients) Intensification Biotherapy Education: Workshops : "Subcutaneous injection education" and "biotherapy management".
* M6 (individual presential or by phone) Assessment of security skills and questionnaires.
* M12 (individual presential or by phone) Assessment of security skills and questionnaires.
2. Control group (individual therapeutic education alone ) :
* M0 (individual) Educational diagnosis and biotherapy education: "subcutaneous injection education" and "biotherapy management".
* M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".
* M6 (individual présential or by phone) Assessment of security skills and questionnaires.
* M12 (individual présential or by phone) Assessment of security skills and questionnaires. Group session proposed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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interventional group
M3 (group with 3 to 10 patients) Intensification Biotherapy Education Workshops : "Subcutaneous injection education" and "biotherapy management
Therapeutic education
Individual and group therapeutic education sessions will consist of :
* acquisition by patient of self-care skills such as performing subcutaneous injection,
* acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...
Control group
M3 (individual) Intensification Biotherapy Education: "Subcutaneous injection education" and "biotherapy management".
Therapeutic education
Individual and group therapeutic education sessions will consist of :
* acquisition by patient of self-care skills such as performing subcutaneous injection,
* acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...
Interventions
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Therapeutic education
Individual and group therapeutic education sessions will consist of :
* acquisition by patient of self-care skills such as performing subcutaneous injection,
* acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ...
Eligibility Criteria
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Inclusion Criteria
* Patient able to complete a questionnaire
* Patient giving informed consent.
* Patient covered by social security
Exclusion Criteria
* Patient previously treated by intravenous biotherapy.
* Protected populations: pregnant women, breastfeeding women, tutorship, trusteeship, deprived of liberty, safeguard of justice.
18 Years
80 Years
ALL
No
Sponsors
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French Society of Rheumatology
OTHER
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Françoise FAYET
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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Chu Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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References
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Gossec L, Fautrel B, Flipon E, Lecoq d'Andre F, Marguerie L, Nataf H, Pallot Prades B, Piperno M, Poilverd RM, Rat AC, Sadji F, Sordet C, Thevenot C, Beauvais C. Safety of biologics: elaboration and validation of a questionnaire assessing patients' self-care safety skills: the BioSecure questionnaire. An initiative of the French Rheumatology Society Therapeutic Education section. Joint Bone Spine. 2013 Oct;80(5):471-6. doi: 10.1016/j.jbspin.2012.11.009. Epub 2013 Aug 20.
Gronning K, Rannestad T, Skomsvoll JF, Rygg LO, Steinsbekk A. Long-term effects of a nurse-led group and individual patient education programme for patients with chronic inflammatory polyarthritis - a randomised controlled trial. J Clin Nurs. 2014 Apr;23(7-8):1005-17. doi: 10.1111/jocn.12353. Epub 2013 Jul 22.
Homer D, Nightingale P, Jobanputra P. Providing patients with information about disease-modifying anti-rheumatic drugs: Individually or in groups? A pilot randomized controlled trial comparing adherence and satisfaction. Musculoskeletal Care. 2009 Jun;7(2):78-92. doi: 10.1002/msc.141.
Koev DJ, Tankova TI, Kozlovski PG. Effect of structured group education on glycemic control and hypoglycemia in insulin-treated patients. Diabetes Care. 2003 Jan;26(1):251. doi: 10.2337/diacare.26.1.251. No abstract available.
Fayet F, Beauvais C, Pereira B, Beranger M, Rodere M, Pallot-Prades B, Peyrard P, Pouplin S, Grandjean M, Chu Miow Lin D, Ardizzone M, Cherillat MS, Tournadre A, Fan A, Soubrier M. Comparison of group versus individual patient education for promoting safety skills of patients with autoimmune rheumatic diseases treated with biologics: a multicentre randomised controlled trial. Clin Rheumatol. 2025 Jan;44(1):487-494. doi: 10.1007/s10067-024-07218-6. Epub 2024 Nov 5.
Other Identifiers
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2018-A00647-48
Identifier Type: OTHER
Identifier Source: secondary_id
CHU-420
Identifier Type: -
Identifier Source: org_study_id