Virtual Rehabilitation Assistant Via Instant Messaging Communication to Promote Adherence to Rehabilitation After Reverse Shoulder Replacement (SIP_LaFe)

Herramienta de Procesamiento de Lenguaje Natural en Dispositivo móvil Inteligente Para Asegurar la Adherencia a la rehabilitación Domiciliaria en cirugías de Artroplastia Invertida de Hombro (NLP-PTAdherence)

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

Study Overview

• Status: Recruiting
• Conditions: Shoulder Osteoarthritis
• Intervention / Treatment: Other: Chatbot; Other: Standard car

Detailed Description

The objective is to evaluate the effectiveness of a Chatbot that interacts with patients via instant messaging to supervise home rehabilitation and increase adherence. Conduct a feasibility study with a pilot sample

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • València, Valencia, Spain, 46026
      • Recruiting
      • Hospital Universitario y Politécnico La Fe
      • Contact: Marta Navarro, MD; Phone Number: 961 24 40 00; Email: mnb18504@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care	Other: Standard car; Rehabilitation program based on standard care, assisted with one education session plus informative brochure
Experimental: Chatbot care	Other: Chatbot; Rehabilitation program based on standard care, but assisted via an instant messaging application using a personal smartphone; Other: Standard car; Rehabilitation program based on standard care, assisted with one education session plus informative brochure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder functionality	measured with the Constant-Murley Score, a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively	0 weeks, 12 weeks
Shoulder pain	Assessed with a numeric pain rating scale, ranging from 0, the worst possible pain, to 10, no pain, with the question: What was your overall pain in the shoulder in the last week?	0 weeks, 12 weeks
Quality of Life	measured with the EQ-5D-5L quetionnaire, which essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.	0 weeks, 12 weeks
Number of sessions of rehabilitation completed	Compliance with rehabilitation, measuring the number of sessions completed	12 weeks

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: SIP_LaFe

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No