Clinical trial NCT01511341: Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases
Official title: Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases and Their Family: a Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Rheumatism
Keywords: Telenursing
Children
Chronic Illness
Nursing
Lead sponsor: University of Applied Sciences of Western Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Réseau d'Etudes aux Confins de la Santé et du Social (RECSS)(HES-SO)
name: University of Lausanne Hospitals
name: Consultation Multisite Romande de Rhumatologie Pédiatrique
name: Ligue Genevoise contre le Rhumatisme
First posted: 2012-01-18
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Satisfaction
timeFrame: 2 years
Secondary outcomes:
measure: Telenursing service utilisation
timeFrame: 2 years
measure: Adherence to therapeutic regimen
timeFrame: 2 years
measure: Cost effectiveness
timeFrame: 2 years
measure: Clinical status (disease activity, QOL)
timeFrame: 2 years
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital of Vaud - Department of Pediatrics
state: Vaud
Study officials:
affiliation: Institut universitaire de formation et de recherche en soins-IUFRS
name: Anne-Sylvie Ramelet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.