Quality of Life, Stoma Colostomy, Stoma Ileostomy
Conditions
Brief summary
In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists. The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites. The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.
Detailed description
France currently has about 80,000 ostomy patients. Stoma placement exposes patients to many surgical or peristomal skin complications which could impair the quality of life of the ostomy patient. The management of ostomy patients varies from institution to institution and according to how the patient's medical equipment is supplied as well as whether or not specialised personnel are available. In the last decade, the market for stoma therapy in France has evolved, with a significant increase in the delivery of equipment by HHNs, meeting a need for patient follow-up and accompaniment. This increased preference of HHNs to use specialist nurses seems to be explained by the added benefits. Early international studies have demonstrated the impact of an enterostomal therapy nurse follow-up on the improvement of ostomy patient's quality of life (QoL) relative to their health. However, none of the studies available today on follow-ups performed by an enterostomal therapist included the French population. Furthermore, the studies show methodological gaps, a limited time span and are based on strong hypotheses. In this context, FSK would like to implement a clinical study to assess the added value on the health-related QoL from the enhanced follow-up of ostomy patients by a HHN including stomal therapists. The interventional group will benefit from delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites. The control group will receive the routine care prescribed by the sites and will be provided with ostomy equipment by FSK.
Interventions
OTHERstoma follow-up
delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites
OTHERstandard of care
routine management of stoma
Sponsors
FSK
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, randomised, comparative, controlled, national and multi-centre study with minimal risks and constraints to routine care.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female ≥ 18 years * Patients with a stoma placed less than 10 days ago * Patients who had a stoma during their current hospitalisation * Patients informed verbally and in writing via the information sheet and who signed the informed consent form.
Exclusion criteria
* Patients in palliative care * Patients participating in another clinical study interested in the management of ostomy patients * Patients not enrolled in a social security system or with the CMU (Couverture maladie universelle \[Universal Health Coverage\]) * Patients under judicial protection or under guardianship * Patients deprived of freedom (in prison and psychiatric patients being treated without consent) * Patients with difficulties understanding or reading French
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 3 months | score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of patient | 3 and 6 months | scale 0-100 |
| Quality of life | 1, 2, 3 and 6 months | Stoma-QOL questionnaire, (min: 0- max: 100), analysis of the mean |
| Cost | 3 and 6 months | • Calculation of resource use at 3 and 6 months per expenditure item (use of services, drug use, medical device and home healthcare service use, MCO (Médecine chirurgie obstétrique \[Obstetric surgery\]) hospitalisations and SSR (Soins de suite et de réadaptation \[Follow-up care and rehabilitation\]) hospitalisations) for each group. |
| Morbidity | 3 and 6 months | readmission rate |
Countries
France
Contacts
Primary ContactIngrid Kuhn
Outcome results
None listed