Quality of Life Clinical Trial
— StomaCareOfficial title:
Quality of Life Impact After Enhanced Follow-up of Ostomy Patients by a Home Healthcare Nursing Service Employing Stomal Therapy Nurse Consultants Compared to Conventional Care
Verified date | September 2021 |
Source | FSK |
Contact | Ingrid Kuhn |
Phone | +33 7 61 47 98 25 |
i.kuhn[@]fsk.fr | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 350 |
Est. completion date | December 2023 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hopital Bicètre | Le Kremlin-Bicêtre | |
France | Hopital Lyon-Sud | Lyon | |
France | Hopital de la Pitié-Salpétrière | Paris | |
France | Hopital HEGP | Paris | |
France | Hopital SAint Louis | Paris | |
France | Hopital Saint-Antoine | Paris | |
France | Hopital Saint-Louis | Paris | |
France | ESPIC FOCH - Digestige Unit | Suresnes | |
France | ESPIC Foch - Urology Unit | Suresnes | |
France | CHU Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
FSK |
France,
Becker A, Schulten-Oberbörsch G, Beck U, Vestweber KH. Stoma care nurses: good value for money? World J Surg. 1999 Jul;23(7):638-42; discussion 642-3. — View Citation
Danielsen AK, Rosenberg J. Health related quality of life may increase when patients with a stoma attend patient education--a case-control study. PLoS One. 2014 Mar 7;9(3):e90354. doi: 10.1371/journal.pone.0090354. eCollection 2014. — View Citation
Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. Ostomy Wound Manage. 2003 Feb;49(2):48-55. — View Citation
Neil N, Inglese G, Manson A, Townshend A. A Cost-Utility Model of Care for Peristomal Skin Complications. J Wound Ostomy Continence Nurs. 2016 Jan-Feb;43(1):62-8. doi: 10.1097/WON.0000000000000194. — View Citation
Persson E, Berndtsson I, Carlsson E, Hallén AM, Lindholm E. Stoma-related complications and stoma size - a 2-year follow up. Colorectal Dis. 2010 Oct;12(10):971-6. doi: 10.1111/j.1463-1318.2009.01941.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy | score from the Stoma-QOL specific questionnaire (min: 0- max: 100), analysis of the mean | 3 months | |
Secondary | Satisfaction of patient | scale 0-100 | 3 and 6 months | |
Secondary | Quality of life | Stoma-QOL questionnaire, (min: 0- max: 100), analysis of the mean | 1, 2, 3 and 6 months | |
Secondary | Quality of life | EQ-5D-5L questionnaire (min: 0- max: 1), analysis of the mean | 1, 2, 3 and 6 months | |
Secondary | Cost | • 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. | 3 and 6 months | |
Secondary | Morbidity | readmission rate | 3 and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Recruiting |
NCT05546931 -
Mobile Health Program for Rural Hypertension
|
N/A | |
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A |