ClinicalTrials.gg
Not yet recruitingNCT07931911TOMO-QALYUpdated Nov 12, 2026

TOMO-QALY: Peer Mentoring in Chronic Kidney Disease

An interventional study of TOMO in Renal Insufficiency, Chronic and Peer Group, sponsored by University Hospital, Caen. Not yet recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University Hospital, Caen · Not applicable, Interventional, and Supportive care

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 238 studies in Renal Insufficiency, Chronic with a site in France — 56 open to participants now, 70 under way, 17 of them phase 3. Renal Insufficiency, Chronic · France.

Planned enrollment
67th of 165
260 · median 170
Started
2027
with 1 other
No phase
63 of 238
24 open now
Primary completion
2029-02
later than 53 of 69 live
Registered
238th of 238
by date

Among the 238 studies in Renal Insufficiency, Chronic with a site in France, this one is the 67th largest by planned enrollment of the 165 interventional ones that give a count, is one of 2 that started in 2027, is one of 63 with no phase, reaches primary completion later than 53 of the 69 other live ones, and was the 238th registered.

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

Browse Renal Insufficiency, Chronic studies →

Open to participants now

56 of the 238 studies in Renal Insufficiency, Chronic with a site in France are open now. Recruiting first, the newest first:

51 more — sign in →

All 56 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 435 Renal Insufficiency, Chronic studies recruiting now, 245 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 238 studies in Renal Insufficiency, Chronic with a site in France, or all of them as a file.
02

Study summary

Background: Patients living with chronic kidney disease (CKD) face numerous therapeutic decisions throughout their care pathway, particularly regarding the choice of kidney replacement therapy modality. In this context, shared decision-making plays a central role in enabling patients to actively participate in treatment decisions according to their preferences and quality-of-life expectations. However, several studies have shown that the information provided to patients may sometimes be insufficient and that patients' preferences are not always aligned with the treatment modalities ultimately initiated.

Patients with CKD may also feel overwhelmed by their diagnosis and by the large amount of medical information they receive. Emotional responses to the disease vary considerably and are associated with heterogeneous needs for information and support, which may contribute to impaired quality of life.

In this context, peer support, based on the sharing of experiences between individuals facing similar situations, may represent a valuable complement to the support provided by healthcare teams.

Methods: A pragmatic, comparative, open-label, randomised, parallel-group, multicentre trial will be conducted involving 260 patients at six nephrology centres in French region. The primary objective is to compare, over a 12-month follow-up period, quality-adjusted life years (QALYs) - which take into account both survival time and health-related quality of life - in patients with stage IV chronic kidney disease, between a group of patients receiving standard care and support from the nephrology team and a group using the TOMO platform in addition to standard care Discussion: At a time when digital technology in healthcare is establishing itself as a means of ensuring access, personalised care and continuity of care, Tomo® offers a structured, secure and supervised peer-support model. We hypothesise that offering peer support, in addition to the standard care provided fro the nephrology team to patients with stage IV chronic kidney disease, should improve their life expectancy and well-being.

03

Conditions studied

  • Renal Insufficiency, Chronic
  • Peer Group

Keywords

  • Chronic kidney disease, information, kidney replacement therapy, peer support, TOMO®
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 years or older with stage 4 chronic kidney disease.
  • Patients affiliated with the French social security system.
  • Patients who have been informed about the study and have provided written .
  • Patients who are able to speak, read, and understand French.

Exclusion criteria

Exclusion Criteria:

  • Patients under guardianship, curatorship, judicial safeguard, or other forms of legal protection.
  • Patients who have difficulty understanding or communicating in French.
  • Patients without internet access (via smartphone, computer, or tablet).
  • Patients under 18 years of age.
  • Patients without an email address or access to an email account.
  • Pregnant or breastfeeding women.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
260 participants (estimated)

Study arms

  • No intervention
    Control

    Patients with stage 4 chronic kidney disease who do not use the TOMO platform or any other digital solution that facilitates connections with peer mentors. Usual care and support provided by the healthcare team remain unchanged. Care organization may vary across participating centers

  • Experimental
    Experimental

    Patients with stage 4 chronic kidney disease who use the TOMO platform, which connects them with a peer mentor living with the same condition. Usual care and support provided by the nephrology team remain unchanged

    Behavioral: TOMO

Interventions

  • BehavioralTOMO

    A digital peer-support intervention connecting patients with stage 4 chronic kidney disease to peer mentors living with the same condition, in addition to usual nephrology care

06

What researchers measure

Primary outcomes

  1. QALYs

    Difference in cumulative quality-adjusted life years (QALYs) between the control and intervention groups. QALYs will be calculated from utility scores derived from the EQ-5D-5L questionnaire using the area under the curve (AUC) method.

    Time frame: Baseline (M0), 3 months (M3), 6 months (M6), and 12 months (M12) after randomization.

07

Study locations

6 sites
  • Nephrology Department, General Hospital
    Avranches, 50300, France
  • Nephrology Department, Private Hospital
    Caen, 14000, France
  • Nephrology Department, University Hospital
    Caen, 14000, France
    • Clémence Béchade · Contactbechade-c@chu-caen.fr · +33231272109
    • Sonia GUILLOUET · Principal investigator
  • Nephrology Departement, General Hospital
    Cherbourg, 50102, France
    • Mathilde Beaumier · Contact+33233207646
  • Nephrology Department, General Hospital
    Flers, 61104, France
  • Nephrology Department, General Hospital
    Saint-Lô, 50009, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2027; primary completion for Feb 2029, 24 months later.

Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 24 months is close to that.

Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Feb 1, 2027
Primary completionEst.
Feb 2029
CompletionEst.
Feb 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07931911
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Feb 1, 2027 (estimated)
Primary completion
Feb 2029 (estimated)
Completion
Feb 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Sonia GUILLOUET
Contact
sonia.guillouet@unicaen.fr
+33231064816
Jean-Jacques DUTHEIL
Contact
dutheil-jj@chu-caen.fr
+33231064816

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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