NCT02200068

Brief Summary

Recommendations of Rheumatoid Arthritis management agree on the necessity of patient self-involvement in the care. In parallel, the observation of the adoption rate of websites directed toward patients may indicate that this involvement is shared by a large number ot the population. However, most of these sites are only informative and few of them offer patients to be engaged to generate their own data that can impact on the patient-physician relationship by easing the dialog and then leading to better mutual understanding. As new web or mobile services allowing patients to self-report their outcomes are flourishing only a very few of them have already addressed the their impact of the patient-physician relationship. The main objective of this study is to quantify the effect of a website (Sanoia) on the quality of patient-doctor interactions, as perceived by the patient using the french translations of the Peppi Questionnaire during the 12 months observation period. In France, the patient protection committee (CPP) has ranked this study in "Soins Courants" (Usual Care).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

13 active sites

Status
completed

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

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 25, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

July 9, 2014

Last Update Submit

June 17, 2016

Conditions

Rheumatoid Arthritis

Keywords

Perceived Efficacy of Patient Physician InteractionsPatient Reported OutcomesPersonal Health Record

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline to 12 months after inclusion of Perceived efficacy by the patient of patient-physician interactions (PEPPI)

    Patients connects to the electronic Case Report Form (e-CRF) and file the French translation of the 5-item PEPPI Questionnaire

    Baseline and Month 12

Secondary Outcomes (10)

  • Rheumatoid Arthritis Impact of Disease (RAID) score

    Baseline, Month 3, Month 6 and Month 12

  • Overall assessment of the patient's Health as measured by a VAS

    Baseline, Month 3, Month 6 and Month 12

  • Patient-Physician communication quality, as assessed by the patient using a Numeric Rating Scale

    Baseline, Month 3, Month 6 and Month 12

  • Overall perceived quality of care, as assessed by the patient via a Numeric Rating Scale

    Baseline, Month 3, Month 6 and Month 12

  • Number of patient's visits to the Rheumatologist from baseline to 12 months after inclusion

    Month 3, Month 6 and Month 12

  • +5 more secondary outcomes

Other Outcomes (1)

  • Value of Perceived efficacy by the patient of patient-physician interactions (PEPPI)

    Month 3 and Month 6

Study Arms (2)

PHR Group

ACTIVE COMPARATOR

This group will have access to a personal health record website SANOIA in addition to all resources they use or find online

Other: SANOIA Website

Non-PHR Group

NO INTERVENTION

This group will not be informed of the Personal Health Record Website and will use Internet as they usually do.

Interventions

SANOIA WebsiteOTHER
PHR Group

Eligibility Criteria

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

You may qualify if:

  • Adult over 18 years.
  • Patient with Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR ) / European League Against Rheumatism (EULAR) 2010 criteria.
  • Patient monitored by the recruiting physician from over a year.
  • Patient access who have access to an Internet broadband equipment other than on a mobile or a a smartphone

You may not qualify if:

  • Patient already participating in a therapeutic clinical trial in rheumatology
  • Patient having no computer literacy and understanding difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University Hospital Jean Minjoz

Besançon, 25030, France

Location

Chu de La Cavale Blanche

Brest, 29069, France

Location

University Hospital Gabriel-Montpied

Clermond-Ferrand, 63003, France

Location

University Hospital of Grenoble - Hôpital Sud

Échirolles, 38434, France

Location

Le Mans Regional Hospital

Le Mans, 72000, France

Location

Private Rheumatologist

Mantes-la-Jolie, 78200, France

Location

University Hospital Lapeyronie

Montpellier, 34295, France

Location

University Hospital Hotel-Dieu

Nantes, 44000, France

Location

University Hospital Saint-Antoine

Paris, 75012, France

Location

University Hospital La Pitié Salpétrière

Paris, 75013, France

Location

University Hospital Cochin

Paris, 75014, France

Location

University Hospital Sud

Rennes, 35203, France

Location

University Hospital Purpan

Toulouse, 31000, France

Location

Related Publications (8)

  • Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.

    PMID: 9670878BACKGROUND

  • Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis. 2010 Sep;69(9):1580-8. doi: 10.1136/ard.2010.138461.

    PMID: 20699241BACKGROUND

  • Gossec L, Dougados M, Rincheval N, Balanescu A, Boumpas DT, Canadelo S, Carmona L, Daures JP, de Wit M, Dijkmans BA, Englbrecht M, Gunendi Z, Heiberg T, Kirwan JR, Mola EM, Matucci-Cerinic M, Otsa K, Schett G, Sokka T, Wells GA, Aanerud GJ, Celano A, Dudkin A, Hernandez C, Koutsogianni K, Akca FN, Petre AM, Richards P, Scholte-Voshaar M, Von Krause G, Kvien TK. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis. 2009 Nov;68(11):1680-5. doi: 10.1136/ard.2008.100271. Epub 2008 Dec 3.

    PMID: 19054825BACKGROUND

  • Pincus T, Bergman MJ, Yazici Y, Hines P, Raghupathi K, Maclean R. An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. Rheumatology (Oxford). 2008 Mar;47(3):345-9. doi: 10.1093/rheumatology/kem364. Epub 2008 Jan 31.

    PMID: 18238788BACKGROUND

  • Guillemin F, Braincon S, Pourel J. [Measurement of the functional capacity in rheumatoid polyarthritis: a French adaptation of the Health Assessment Questionnaire (HAQ)]. Rev Rhum Mal Osteoartic. 1991 Jun;58(6):459-65. French.

    PMID: 1896787BACKGROUND

  • Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka K, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, Sokka-Isler T, Wong JB, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar;73(3):492-509. doi: 10.1136/annrheumdis-2013-204573. Epub 2013 Oct 25.

    PMID: 24161836BACKGROUND

  • Bossert M, Prati C, Vidal C, Bongain S, Toussirot E, Wendling D. Evaluation of self-report questionnaires for assessing rheumatoid arthritis activity: a cross-sectional study of RAPID3 and RADAI5 and flare detection in 200 patients. Joint Bone Spine. 2012 Jan;79(1):57-62. doi: 10.1016/j.jbspin.2011.03.014. Epub 2011 May 6.

    PMID: 21550283BACKGROUND

  • Gossec L, Cantagrel A, Soubrier M, Berthelot JM, Joubert JM, Combe B, Czarlewski W, Wendling D, Dernis E, Grange L, Beauvais C, Perdriger A, Nataf H, Dougados M, Servy H. An e-health interactive self-assessment website (Sanoia(R)) in rheumatoid arthritis. A 12-month randomized controlled trial in 320 patients. Joint Bone Spine. 2018 Dec;85(6):709-714. doi: 10.1016/j.jbspin.2017.11.015. Epub 2017 Dec 12.

    PMID: 29246532DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 25, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations

FR(13)