NCT06153381

Brief Summary

reverse shoulder replacement surgery is performed to improve the functionality and reduce pain of the affected shoulder. Now, it is necessary to carry out an appropriate rehabilitation process to optimize surgical results. The lack of health resources makes it essential for the patient to work autonomously once hospital rehabilitation is completed. But lack of adherence is one of the main barriers to recovery

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

November 22, 2023

Last Update Submit

December 4, 2023

Conditions

Shoulder Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Shoulder disability

    This is measured with the Quick Dash questionnaire, a self-reported survey of 11 items designed to assess symptoms and ability to perform certain activities. At least 10 items should be answered to calculate a score. Each answer can be scored from one to five, and the average value is calculated, thus obtaining a score from one to five. Then, to express the score in percentages, 1 is subtracted from the result and then multiplied by 25. The higher the score, the greater the disability.

    0 weeks, 12 weeks

Secondary Outcomes (4)

  • Shoulder functionality

    0 weeks, 12 weeks

  • Shoulder pain

    0 weeks, 12 weeks

  • Quality of Life

    0 weeks, 12 weeks

  • Number of sessions of rehabilitation completed

    12 weeks

Study Arms (2)

Chatbot care

EXPERIMENTAL
Other: ChatbotOther: Standard car

Standard care

ACTIVE COMPARATOR
Other: Standard car

Interventions

ChatbotOTHER

Rehabilitation program based on standard care, but assisted via an instant messaging application using a personal smartphone

Chatbot care
Standard carOTHER

Rehabilitation program based on standard care, assisted with one education session plus informative brochure

Chatbot careStandard care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing reverse shoulder replacement
  • With a personal smartphone
  • An instant messaging application installed
  • Familiar with the use of such an application (i.e., at least three accessess per week)
  • Able to write and read in the Spanish language

You may not qualify if:

  • Condition, whether cognitive, neurological, integrative or musculoskeletal, that obviously prevents understanding or performing the exercises of the rehabilitation program or may pose a risk to the patient's health.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2023

First Posted

December 1, 2023

Study Start

September 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

ES(1)