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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Applied Sciences of Western Switzerland
Sponsor:
Collaborators:
Swiss National Science Foundation
Réseau d'Etudes aux Confins de la Santé et du Social (RECSS)(HES-SO)
University of Lausanne Hospitals
Consultation Multisite Romande de Rhumatologie Pédiatrique
Ligue Genevoise contre le Rhumatisme
Information provided by (Responsible Party):
Anne-Sylvie Ramelet, University of Applied Sciences of Western Switzerland
ClinicalTrials.gov Identifier:
NCT01511341
First received: January 12, 2012
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Inflammatory Rheumatism
Behavioral: Telenursing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases and Their Family: a Crossover Trial

Resource links provided by NLM:


Further study details as provided by University of Applied Sciences of Western Switzerland:

Primary Outcome Measures:
  • Satisfaction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Mixed methods, with Client Satisfaction Questionnaire (CSQ-8), and semi-structured interview


Secondary Outcome Measures:
  • Telenursing service utilisation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Adherence to therapeutic regimen [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Parent Adherence Report Questionnaire (PARQ) and Child Adherence Report Questionnaire (CARQ)

  • Cost effectiveness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Clinical status (disease activity, QOL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Juvenile Arthritis Disease Activity Score (JADAS) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR)


Estimated Enrollment: 48
Study Start Date: August 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telenursing 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.
No Intervention: Standard practice
Group receive the standard practice, without telephone nursing intervention.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511341

Contacts
Contact: Anne-Sylvie Ramelet, PhD + 41 21 316 81 08 Anne-Sylvie.Ramelet@hesav.ch

Locations
Switzerland
University Hospital of Vaud - Department of Pediatrics Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Joachim Rapin, Nursing    + 41 21 314 13 37    Joachim.Rapin@chuv.ch   
Sub-Investigator: Michaël Hofer, MD         
Sub-Investigator: Béatrice Fonjallaz, Nursing         
Sub-Investigator: Joachim Rapin, Nursing         
Sponsors and Collaborators
University of Applied Sciences of Western Switzerland
Swiss National Science Foundation
Réseau d'Etudes aux Confins de la Santé et du Social (RECSS)(HES-SO)
University of Lausanne Hospitals
Consultation Multisite Romande de Rhumatologie Pédiatrique
Ligue Genevoise contre le Rhumatisme
Investigators
Principal Investigator: Anne-Sylvie Ramelet, PhD University of Applied Sciences of Western Switzerland
  More Information

Additional Information:
No publications provided by University of Applied Sciences of Western Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne-Sylvie Ramelet, Professor HES-S2, University of Applied Sciences of Western Switzerland
ClinicalTrials.gov Identifier: NCT01511341     History of Changes
Other Study ID Numbers: SNSF-13DPD6_132135
Study First Received: January 12, 2012
Last Updated: September 30, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Applied Sciences of Western Switzerland:
Telenursing
Children
Chronic Illness
Nursing

Additional relevant MeSH terms:
Rheumatic Diseases
Rheumatic Fever
Arthritis
Bacterial Infections
Connective Tissue Diseases
Gram-Positive Bacterial Infections
Joint Diseases
Musculoskeletal Diseases
Streptococcal Infections

ClinicalTrials.gov processed this record on November 25, 2014