HOSPITEL: Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05680259

Collaborator

(none)

Enrollment

Location

Arms

13.8

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Digital technologies could reduce the length of hospital stay and improve post-operative recuperation after discharge by offering a remote follow-up. No study has investigated the effects of connected follow-up on lumbar spine inpatients.

The purpose of this project is to assess the effects of connected follow-up on pain and quality of life after lumbar spine surgery.

Condition or Disease	Intervention/Treatment	Phase
Lumbar Spine Surgery Quality of Life Pain	Other: Maela connected follow-up Other: traditional follow-up	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery

Actual Study Start Date :

Oct 6, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Maela connected follow-up patient will benefit of the Maela connected follow-up	Other: Maela connected follow-up Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.
Active Comparator: control group control group with a traditional follow-up	Other: traditional follow-up medical recommendations and prescriptions at hospital discharge. Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.

Arm

Intervention/Treatment

Experimental: Maela connected follow-up

patient will benefit of the Maela connected follow-up

Other: Maela connected follow-up

Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.

Active Comparator: control group

control group with a traditional follow-up

Other: traditional follow-up

medical recommendations and prescriptions at hospital discharge. Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.

Outcome Measures

Primary Outcome Measures

Variation of number of well-being patients in both groups [two months]
Variation of number of well-being patients in both groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First ever lumbar spine surgery in the context of a degenerative spinal pathology
Age between 18 and 60 yo
Providing free and informed consent to participate
Having a smartphone able to process MAELA application

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT05680259

Other Study ID Numbers:

PI2019_843_0016

First Posted:

Jan 11, 2023

Last Update Posted:

Jan 11, 2023

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

Study Results

No Results Posted as of Jan 11, 2023