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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05720910
Other study ID # IB2022-03
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2023
Est. completion date January 2026

Study information

Verified date January 2023
Source Institut Bergonié
Contact kinkle VODJOGBE
Phone 05.56.33.33.33 (poste 6184)
Email frone@bordeaux.unicancer.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of GERONTE STUDY is to evaluate the effectiveness of the GERONTE, ICT-based, integrated care pathway to improve patient 6-month quality of life, in France. Study design is a stepped wedge randomised controlled trial. Clusters will be participating hospitals, comprising eight investigating sites in total (Figure 2). This is a stepped wedge of cross-over type. Patients included at each "step" are different individuals. The first "step" is a reference measurement where none of the clusters will implement the intervention. The investigating sites will be randomly drawn to determine the order in which they will implement the intervention, by "steps" of two months. The primary endpoint is the Quality of Life assessed by the EORTC QLQ-C30 (version 3.0) questionnaire at 6 months after GERONTE implementation. It has 3 sub-scores that will be analysed independently, with alpha risk adjustment.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
GERONTE
The clinical model behind GERONTE is to regroup all health professionals taking care of a multimorbid patient, into a common care coordination pathway

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Institut Bergonié EUCLID Clinical Trial Platform, University of Bordeaux

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life assessed by the EORTC quality of life questionnaire (EORTC QLQ-C30 ) Quality of life assessed by the quality of life questionnaire (EORTC QLQ-C30) questionnaire at 6 months after inclusion:
Normalised global health status score
Normalised score of the physical functioning scale
Normalised score of the emotional functioning scale the minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result.
6 months
Secondary Quality of life of elders cancer patients Scores of the quality of life questionnaire for elderly cancer patients.(QLQ-ELD14). The minimum value is 14 and the maximum value is 40, and higher scores mean a worse result. baseline 3, 9 and 12 months
Secondary Quality of life by the EORTC quality of life questionnaire (EORTC QLQ-C30 ) The quality of life questionnaire (QLQ-C30) scores. The minimum value of the EORTC QLQ-C30 is 30 and the maximum value is 126, and higher scores mean a worse result. baseline 3, 9 and 12 months
Secondary Survival Overall survival and progression-free survival at 12 months
Secondary Patient frailty Score of the Clinical frailty scale baseline, 3, 6, 9 and 12 months
Secondary Patient autonomy, Dependence score of the Activities of Daily Living scale (ADL); Proportion of patients living at home; Number of completed chair stands in 30 seconds baseline, 3, 6, 9 and 12 months
Secondary Patient weight evolution Weight in Kilograms baseline, 3, 6, 9 and 12 months
Secondary Patient anxiety Score of Hospital Anxiety and Depression (HAD) scale. The minimum value is 0 and the maximum value is 21, and higher scores mean a worse result. baseline, 3, 6, 9 and 12 months
Secondary institutionalisation Proportion of patient institutionalised per participants 6 and 12 months
Secondary unscheduled hospitalisations Proportion of unscheduled hospitalisations per participants 6 and 12 months
Secondary Cost per life years gained using utility assessed through normalised scores of EQ-5D-5L questionnaire baseline, 3, 6, 9 and 12 months
Secondary Caregiver burden in health, psychological well-being, finances, social life and relationship with patient Zarit Burden Interview baseline, 3, 6, 9 and 12 months
Secondary Patient experience of person-centered coordinated care Person-Centered Coordinated Care Experience Questionnaire (P3CEQ)The minimum value is 0 and the maximum value is 45, and higher scores mean a better result. 6 and 12 months
Secondary Patient, physician and health-professionals-reported overall satisfaction with the IC technology of the GERONTE system Score derived from the mHealth App Usability Questionnaire (MAUQ) for standalone mHealth Apps using the Patient version for patient satisfaction and the provider version for physician and health-professional.The minimum value is 0 and the maximum value is 126, and higher scores mean a better result. 6 and 12 months
Secondary GERONTE patient-centered system implementation and usage use of the HolisTM GV software measures, for instance: number and frequency of connections. 6 months
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