- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01511341
Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases
Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases and Their Family: a Crossover Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1011
- University Hospital of Vaud - Department of Pediatrics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction
Time Frame: 2 years
|
Mixed methods, with Client Satisfaction Questionnaire (CSQ-8), and semi-structured interview
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Telenursing service utilisation
Time Frame: 2 years
|
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
|
Adherence to therapeutic regimen
Time Frame: 2 years
|
Parent Adherence Report Questionnaire (PARQ) and Child Adherence Report Questionnaire (CARQ)
|
2 years
|
Cost effectiveness
Time Frame: 2 years
|
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
|
Clinical status (disease activity, QOL)
Time Frame: 2 years
|
Juvenile Arthritis Disease Activity Score (JADAS) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR)
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Anne-Sylvie Ramelet, PhD, Institut universitaire de formation et de recherche en soins-IUFRS
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNSF-13DPD6_132135
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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