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

Primary Purpose

Inflammatory Rheumatism

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Telenursing
Sponsored by
University of Applied Sciences of Western Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inflammatory Rheumatism focused on measuring Telenursing, Children, Chronic Illness, Nursing

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of Vaud - Department of Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telenursing

Standard practice

Arm Description

Group receive the standard practice, without telephone nursing intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Adherence to therapeutic regimen
Parent Adherence Report Questionnaire (PARQ) and Child Adherence Report Questionnaire (CARQ)
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.
Clinical status (disease activity, QOL)
Juvenile Arthritis Disease Activity Score (JADAS) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR)

Full Information

First Posted
January 12, 2012
Last Updated
February 3, 2015
Sponsor
University of Applied Sciences of Western Switzerland
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
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1. Study Identification

Unique Protocol Identification Number
NCT01511341
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Applied Sciences of Western Switzerland
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Rheumatism
Keywords
Telenursing, Children, Chronic Illness, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telenursing
Arm Type
Experimental
Arm Title
Standard practice
Arm Type
No Intervention
Arm Description
Group receive the standard practice, without telephone nursing intervention.
Intervention Type
Behavioral
Intervention Name(s)
Telenursing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Satisfaction
Description
Mixed methods, with Client Satisfaction Questionnaire (CSQ-8), and semi-structured interview
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Telenursing service utilisation
Description
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.
Time Frame
2 years
Title
Adherence to therapeutic regimen
Description
Parent Adherence Report Questionnaire (PARQ) and Child Adherence Report Questionnaire (CARQ)
Time Frame
2 years
Title
Cost effectiveness
Description
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.
Time Frame
2 years
Title
Clinical status (disease activity, QOL)
Description
Juvenile Arthritis Disease Activity Score (JADAS) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Sylvie Ramelet, PhD
Organizational Affiliation
Institut universitaire de formation et de recherche en soins-IUFRS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Vaud - Department of Pediatrics
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28716081
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.
Results Reference
derived
PubMed Identifier
24939642
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.
Results Reference
derived
Links:
URL
http://p3.snf.ch/project-132135
Description
Swiss National Science Foundation

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

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