NCT01511341

Brief Summary

Paediatric rheumatisms represent a large group of inflammatory and non-inflammatory diseases of the locomotion system. The annual rate incidence of children diagnosed with rheumatic disease in Switzerland (canton of Vaud) is 56.8 for 100'000 children. These children experience a chronic course of the disease impacting on their quality of life and family functioning. Their medical treatment is significant and may last for life. Caring for these children involves a multidisciplinary approach. Control of the disease and management of the symptoms becomes of foremost importance to minimise disability and pain. In addition to medical care, the supporting role of nurses in the care of children with rheumatic diseases and their family aims to limit the potential for further deformity, disability, and psychological complications. In particular, they play a key role in supporting the specialist team caring for patients with rheumatism disease, recognising poor disease control and the need for changes in treatment, providing a resource to patients on treatment options and how to access additional support and advice, and identifying best practice to achieve optimal outcomes for the patients and their family. Nurses also ensure the link between medical practitioner, other health providers, and family, thus play a key role in the follow-up care of the child and its family. Follow-up of children and their family can be ensured by regular telephone consultation (telenursing) made by experienced nurse specialists in rheumatology. However, the effectiveness of telenursing remains to be proven in children with chronic rheumatic diseases. The aim of this study is, therefore, to evaluate the effect of a telephone nursing intervention on the outcomes of family and children with rheumatism chronic disease. This randomised crossover, experimental longitudinal study will be carried out in the outpatient clinic of paediatric rheumatology of a tertiary referral hospital in canton of Vaud. The population will consist of children newly diagnosed with inflammatory rheumatologic diseases and one of their parent. The nurse-led intervention will consist of providing a monthly telephone call by a qualified and experienced nurse specialist in paediatric rheumatology and TN to ensure follow-up of the children and their family. The intervention will focus on providing affective support, health information, and aid to making decision.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

3.1 years

First QC Date

January 12, 2012

Last Update Submit

February 3, 2015

Conditions

Inflammatory Rheumatism

Keywords

TelenursingChildrenChronic IllnessNursing

Outcome Measures

Primary Outcomes (1)

  • Satisfaction

    Mixed methods, with Client Satisfaction Questionnaire (CSQ-8), and semi-structured interview

    2 years

Secondary Outcomes (4)

  • Telenursing service utilisation

    2 years

  • Adherence to therapeutic regimen

    2 years

  • Cost effectiveness

    2 years

  • Clinical status (disease activity, QOL)

    2 years

Study Arms (2)

Telenursing

EXPERIMENTAL
Behavioral: Telenursing

Standard practice

NO INTERVENTION

Group receive the standard practice, without telephone nursing intervention.

Interventions

TelenursingBEHAVIORAL

The nurse-led intervention will consist of providing a monthly telephone call by a qualified and experienced nurse specialist in paediatric rheumatology and TN to ensure follow-up of the children and their family. The intervention will focus on providing affective support, health information, and aid to making decision.

Telenursing

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children under the age of 17 years at the time of enrolment into the study
  • Newly diagnosed (within 24 months from the enrolment date) with inflammatory rheumatologic diseases
  • Registered as outpatient in the clinic of paediatric rheumatology
  • A parent (the mother or the father or the guardian) on behalf of their children.

You may not qualify if:

  • Children and parents who do not understand and speak French
  • No access to a telephone line.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Vaud - Department of Pediatrics

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • Ramelet AS, Fonjallaz B, Rio L, Zoni S, Ballabeni P, Rapin J, Gueniat C, Hofer M. Impact of a nurse led telephone intervention on satisfaction and health outcomes of children with inflammatory rheumatic diseases and their families: a crossover randomized clinical trial. BMC Pediatr. 2017 Jul 17;17(1):168. doi: 10.1186/s12887-017-0926-5.

    PMID: 28716081DERIVED

  • Ramelet AS, Fonjallaz B, Rapin J, Gueniat C, Hofer M. Impact of a telenursing service on satisfaction and health outcomes of children with inflammatory rheumatic diseases and their families: a crossover randomized trial study protocol. BMC Pediatr. 2014 Jun 18;14:151. doi: 10.1186/1471-2431-14-151.

    PMID: 24939642DERIVED

Related Links

MeSH Terms

Conditions

Rheumatic FeverChronic Disease

Interventions

Telenursing

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NursingProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care Management

Study Officials

  • Anne-Sylvie Ramelet, PhD

    Institut universitaire de formation et de recherche en soins-IUFRS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor HES-S2

Study Record Dates

First Submitted

January 12, 2012

First Posted

January 18, 2012

Study Start

August 1, 2011

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

CH(1)