Renal InsufficiencyESPAIRNCT02468440
Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant
A study testing ESPAIR in people with Renal Insufficiency, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Treatment care of end-stage renal insufficiency is an important public health issue. The balance between patients waiting for a kidney transplant and available graft raises questions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- ESPAIR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2015to 14 Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with renal insufficiency on dialysis or not
- Registered on transplant list
Who cannot join
- Patient with psychological disorder
- transplantation from living donor
- Patients with renal transplant antecedent
Trial locations and contacts
1 site in 1 country.
About this study
Treatment care of end-stage renal insufficiency is an important public health issue. The balance between patients waiting for a kidney transplant and available graft raises questions. Because of the non-adherence, risk of graft loss is increased to 7 times so in this trial patients will experiment an educational therapy's program as soon as they register on the transplant list.
- Conditions
- Renal Insufficiency
- Being tested
- ESPAIR
- Keywords
- renal insufficiency, kidney transplant, educational therapy
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPAIROther
ESPAIR is an educational therapy's program with 6 group session,and if patients ask for it, individual session are possible
| Study group | Role | What they receive |
|---|---|---|
| ESPAIR | Experimental | Patients with an educational therapy's program since registration in transplant list. Receives: Other: ESPAIR |
| normal care | No intervention | Patients without educational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life Questionnaire
Quality of life 6 months after registration on transplant list.
Measured: 6 months
Secondary outcomes (3)
Quality of life Questionnaire
Quality of life one year after registration on transplant list.
Measured: One year
Quality of life Questionnaire
Quality of life on the day of the transplantation
Measured: 1 day
Composite measure of impact of educational therapy's program
Impact of educational therapy's program on anxiety, knowledge to prepare transplant, life hygiene, and patient compliance.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start2 Jun 2015
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure Esposito, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468440
- Sponsor's protocol ID
- 14 7314 02
- Other IDs
- 2015/20
- Acronym
- ESPAIR
- Status last verified
- Apr 2019
- First submitted
- 7 Jun 2015
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ESPAIR, an Educational Therapy's Program of Patients With Renal Insufficiency Before Kidney Transplant
- ClinicalTrials.gov ID
- NCT02468440
- Acronym / sponsor ID
- ESPAIR / 14 7314 02
- Conditions
- Renal Insufficiency
- Keywords
- renal insufficiency, kidney transplant, educational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 2 Jun 2015 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 10 Jun 2015 (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.
Treatment care of end-stage renal insufficiency is an important public health issue. The balance between patients waiting for a kidney transplant and available graft raises questions. Because of the non-adherence, risk of graft loss is increased to 7 times so in this trial patients will experiment an educational therapy's program as soon as they register on the transplant list.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPAIR | Experimental | Other: ESPAIRPatients with an educational therapy's program since registration in transplant list. |
| normal care | No intervention | –Patients without educational therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with renal insufficiency on dialysis or not
- Registered on transplant list
Key exclusion criteria (3 listed)
- Patient with psychological disorder
- transplantation from living donor
- Patients with renal transplant antecedent
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 |
|---|---|---|
| ESPAIRESPAIR is an educational therapy's program with 6 group session,and if patients ask for it, individual session are possible | Other | ESPAIR |
Primary outcome
Quality of life Questionnaire
Time frame: 6 months
Quality of life 6 months after registration on transplant list.
3 secondary outcomes
Quality of life Questionnaire
Time frame: One year
Quality of life Questionnaire
Time frame: 1 day
Composite measure of impact of educational therapy's program
Time frame: 6 months
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 2 Apr 2019.
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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.
Laure Esposito, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPAIR in people with Renal Insufficiency, run by University Hospital, Toulouse at 1 site in France.
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 2 inclusion and 3 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 2 Apr 2019. 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 France. 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?
Quality of life Questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2019.