Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases

Inflammatory Rheumatism Clinical Trial

Official title:

Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases and Their Family: a Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511341
• Other study ID #: SNSF-13DPD6_132135
• Status: Completed
• Phase: N/A
• First received: January 12, 2012
• Last updated: February 3, 2015
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: University of Applied Sciences of Western Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Inflammatory Rheumatism
• Rheumatic Diseases
• Rheumatic Fever

Intervention

Behavioral:
• Telenursing
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.

Locations

Country	Name	City	State
Switzerland	University Hospital of Vaud - Department of Pediatrics	Lausanne	Vaud

Sponsors (6)

Lead Sponsor	Collaborator
University of Applied Sciences of Western Switzerland	Consultation Multisite Romande de Rhumatologie Pédiatrique, Ligue Genevoise contre le Rhumatisme, Réseau d'Etudes aux Confins de la Santé et du Social (RECSS)(HES-SO), Swiss National Science Foundation, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction	Mixed methods, with Client Satisfaction Questionnaire (CSQ-8), and semi-structured interview	2 years	No
Secondary	Telenursing service utilisation	Telenursing service utilisation will be recorded in terms of number, time and duration of calls, who made the call, the nature of the call, decision made, description of the plan for action, and follow-through of the advice.	2 years	No
Secondary	Adherence to therapeutic regimen	Parent Adherence Report Questionnaire (PARQ) and Child Adherence Report Questionnaire (CARQ)	2 years	No
Secondary	Cost effectiveness	Cost will be descriptive in nature and be estimated by calculating the cost related to the time for the use of the service by a qualified nurse versus what the parents would have done if the service was not avalaible.	2 years	No
Secondary	Clinical status (disease activity, QOL)	Juvenile Arthritis Disease Activity Score (JADAS) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR)	2 years	No

External Links

•   Swiss National Science Foundation