Digital Healthcare App After Total Hip Arthroplasty

May 14, 2024 updated by: Schulthess Klinik

Assessing the Feasibility of a Digital Healthcare App for Patient Rehabilitation After Total Hip Arthroplasty

This study examines the effectiveness of rehabilitation after hip replacement surgery using a specialised app called Akina Cloud. Medical professionals at the Schulthess Clinic will provide detailed information about the study. Participants must meet certain eligibility requirements. There will be time for consideration before enrolment. A demonstration of how to use the app will be provided upon agreement. Participants will be shown how to set up their profile and interact with a real therapist who will provide feedback. The initial 30-minute introduction is scheduled to take place a few days after surgery while still in hospital. Participants will be asked to complete several questionnaires. The rehabilitation process involves using the app for at least 12 weeks, at least three times a week, for 20-30 minutes per session. Direct communication with the therapist via the app is available for any queries. Follow-up questionnaires will be emailed at 6 and 12 weeks, after training, and again at 26 weeks to assess progress and feedback on the use of the app. Each session with the app lasts about 20 minutes and the questionnaire takes about 30 minutes to complete.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Informed Consent signed by the subject
  • Unilateral initial implantation of a minimally-invasive hip endoprosthesis
  • Age between 18 and 75 years old
  • Ownership of a private laptop or desktop computer
  • Stable internet connection at home
  • Familiarity with the use of laptop or desktop computer

Exclusion Criteria:

  • Bilateral initial implantation of a minimally-invasive hip endoprosthesis
  • Not fluent in German or English
  • Other conditions where active therapy is contraindicated
  • Neurological diseases that limit the ability to walk
  • Chronic lower limb pain
  • Rheumatological diseases
  • Other inflammatory diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Akina Cloud
Device: Akina Cloud
Akina Cloud is a digital health application that supports the therapeutic training of people with musculoskeletal conditions. It provides two therapeutic training programs for patients, one for each specific indication. Patients have continuous access to these programs through Akina Cloud, allowing them to independently complete nine training sessions without supervision. A minimum of three sessions per week is recommended, but patients have the option to engage in daily sessions if preferred. These therapy programs are based on current treatment guidelines and supported by relevant scientific research. They include customizable physical exercises tailored to individual needs and difficulty levels. Patients receive audio-visual guidance during these exercise sessions to ensure proper execution. Exercise therapy has demonstrated its ability to reduce pain, improve physical function, and enhance the overall quality of life for patients suffering from back pain and hip osteoarthritis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of completed training sessions and the number of repetitions per sessionweeks of training.
Time Frame: after 12 weeks
after 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intrinsic Motivation Inventory (IMI)
Time Frame: Baseline, 6 weeks, 12 weeks
Intrinsic motivation inventory (IMI) consists of 6 subscales, the items are rated on a Likert scale ranging from 1 ("not at all true") to ("very true") for each item. A higher score indicates stronger intrinsic motivation.
Baseline, 6 weeks, 12 weeks
Net Promoter Score (NPS)
Time Frame: 6 weeks, 12 weeks
The NPS is a metric used to assess customer loyalty and satisfaction by asking a single question: "How likely is it that you would recommend our company/product/service to a friend or colleague?"The scale ranges form 0 to 10. A higher score indicates stronger intrinsic motivation.
6 weeks, 12 weeks
Post-Study System Usability Questionnaire (PSSUQ)
Time Frame: 6 weeks, 12 weeks
The Post-Study System Usability Questionnaire is a standardised questionnaire desigend to evaluate users' perceptions of the usability of a system of product after they have interacted with it.The questionnaire consists of a set of Likert-scale questions that cover various aspects of the user experience. The lower the score, the better the performance and satisfaction.
6 weeks, 12 weeks
Hip disability and Osteoarthritis Outcome Score
Time Frame: 6 weeks, 12 weeks, 26 weeks
The Hip disability and Osteoarthritis Outcome Score is a self-report questionnnaire with five subsets (pain, symptoms, activities of daily living, sports and recreations and quality in life). The scores range from 0 to 100, where a higehr score indicate less ssymptoms and disability.
6 weeks, 12 weeks, 26 weeks
International Physical Activity Questionnaire
Time Frame: 6 weeks, 12 weeks, 26 weeks
The questionnaire covers activities such as work-related, transportation, household chores, and leisure-time activities. The responses are then used to categorise individuals into different levels of physical activity, ranging from low to high.
6 weeks, 12 weeks, 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Schulthess Klinik

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-D0008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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