Inflammatory RheumatismNCT01511341
Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases
A study testing Telenursing in people with Inflammatory Rheumatism, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Inflammatory Rheumatism
- What is being tested?
- Telenursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Children and parents who do not understand and speak French
- No access to a telephone line.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Vaud - Department of Pediatrics
Lausanne, Canton of Vaud, 1011
About this study
Official title: 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.
- Conditions
- Inflammatory Rheumatism
- Being tested
- Telenursing
- Keywords
- Telenursing, Children, Chronic Illness, Nursing
- Medical subject headings
- Rheumatic Fever, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelenursingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Telenursing | Experimental | Not described Receives: Behavioral: Telenursing |
| Standard practice | No intervention | Group receive the standard practice, without telephone nursing intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction
Mixed methods, with Client Satisfaction Questionnaire (CSQ-8), and semi-structured interview
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 2 years
Adherence to therapeutic regimen
Parent Adherence Report Questionnaire (PARQ) and Child Adherence Report Questionnaire (CARQ)
Measured: 2 years
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.
Measured: 2 years
Clinical status (disease activity, QOL)
Juvenile Arthritis Disease Activity Score (JADAS) and Juvenile Arthritis Multidimensional Assessment Report (JAMAR)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory RheumatismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences of Western Switzerland
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Anne-Sylvie Ramelet, University of Applied Sciences of Western Switzerland
- Investigators
- Anne-Sylvie Ramelet, PhD, Principal investigator, Institut universitaire de formation et de recherche en soins-IUFRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511341
- Sponsor's protocol ID
- SNSF-13DPD6_132135
- Status last verified
- Feb 2015
- First submitted
- 12 Jan 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28716081Ramelet 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.
PubMed 24939642
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Telenursing Service on Satisfaction and Health Outcomes of Children With Inflammatory Rheumatic Diseases and Their Family: a Crossover Trial
- ClinicalTrials.gov ID
- NCT01511341
- Acronym / sponsor ID
- SNSF-13DPD6_132135
- Conditions
- Inflammatory Rheumatism
- Keywords
- Telenursing, Children, Chronic Illness, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Applied Sciences of Western SwitzerlandUniversity, hospital or other
- 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
- Study start
- Aug 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telenursing | Experimental | Behavioral: Telenursing |
| Standard practice | No intervention | –Group receive the standard practice, without telephone nursing intervention. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Children and parents who do not understand and speak French
- No access to a telephone line.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelenursingThe 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. | Behavioural | Telenursing |
Primary outcome
Satisfaction
Time frame: 2 years
Mixed methods, with Client Satisfaction Questionnaire (CSQ-8), and semi-structured interview
4 secondary outcomes
Telenursing service utilisation
Time frame: 2 years
Adherence to therapeutic regimen
Time frame: 2 years
Cost effectiveness
Time frame: 2 years
Clinical status (disease activity, QOL)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Derived from this study: PubMed 28716081Ramelet 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.
- Derived from this study: PubMed 24939642Ramelet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Sylvie Ramelet, PhD principal investigator
Institut universitaire de formation et de recherche en soins-IUFRS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telenursing in people with Inflammatory Rheumatism, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01511341, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.