Evaluation of the Effect of Using WeChat Applet to Intervene in the Home Functional Exercise of Patients After Anterior Cruciate Ligament Reconstruction Based on the Health Belief Model

July 4, 2021 updated by: Peking University Third Hospital
Based on the home rehabilitation exercise of patients undergoing ACL reconstruction, the existing WeChat applet of sports medicine of the Third Hospital of Beijing Medical University is optimized to be used as a health education tool to guide patients undergoing home rehabilitation exercise after ACL reconstruction.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

With the development of national fitness and sports, the incidence of ACL injury is increasing year by year. ACL reconstruction is the best way to treat ACL injuries, and the success rate of the operation is high, but patients still need to recover after surgery, otherwise, it will be difficult to fully restore knee joint function. However, my country's rehabilitation medical resources are obviously insufficient. After discharge from the hospital, ACL reconstruction patients usually go home and exercise at home according to the rehabilitation plan formulated by the surgeon or rehabilitation physician. However, compliance is still poor, and rehabilitation is relatively difficult to achieve the expected results, which affects the lives of patients quality. The WeChat official account and its affiliated mini-programs have been widely used in different health fields as a means of health communication. The health belief model is a guiding theory commonly used in the field of health education to guide patients to make behavior changes. This study intends to use the functional advantages of the WeChat applet to explore the optimization of the existing Peking University Third Hospital Sports Medicine WeChat applet based on the health belief model and to use the postoperative rehabilitation of patients undergoing ACL injury reconstruction as a pilot to evaluate the optimized The WeChat Mini Program can improve the intervention effect of patients' home functional exercise compliance after ACL injury reconstruction, to provide effective health education for more extensive sports medicine-related home functional exercises, improve their rehabilitation effects and quality of life, and better To ensure the efficacy of surgery.

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 (Actual)

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.
120

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Between 18 years old (including 18 years old) and 45 years old;
  2. Patients who underwent simple ACL reconstruction for the first time, combined with cartilage trimming and partial meniscus resection, and had the same postoperative rehabilitation plan;
  3. Those who have basic literacy and communication skills;
  4. Those who have a smartphone, can use WeChat or can learn to use WeChat;

Exclusion Criteria:

  1. Have a history of joint infection, joint tuberculosis or osteomyelitis, or have undergone surgery in the lower limbs within 6 months;
  2. Combined with severe heart, brain, kidney, and other organ dysfunction;
  3. Patients with other severe knee joint disease injuries;
  4. The patient is accompanied by mental illness or cognitive impairment, unable to study and participate in rehabilitation training;
  5. Those who have participated in other similar rehabilitation function training programs, or transferred to other medical institutions for rehabilitation after being discharged from the hospital;
  6. Those who have not signed the informed consent.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
No Intervention: Patients who are given regular home functional exercises and discharged from the hospital
Discharge guidance using regular home function exercises, that is, existing regular missions and paper-based brochures
Active Comparator: Patients who are guided by conventional discharge guidance and the optimized WeChat official account
Use regular discharge guidance and optimized WeChat public account guidance
Behavioral: WeChat Mini Program
Through the WeChat applet, it provides services such as visit content configuration, self-image configuration, self-image measurement configuration, and visit reminders.

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
Measure Description
Time Frame
Changes in range of motion of knee joint
Time Frame: 2 weeks, 6 weeks and 12 weeks after surgery
Changes in range of motion of the knee between two time points
2 weeks, 6 weeks and 12 weeks after surgery

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
Visual pain score during knee motion angle exercise
Time Frame: 2 weeks, 6 weeks and 12 weeks after surgery
Visual pain score during knee motion angle exercise were measured at 2,6 and 12 weeks.
2 weeks, 6 weeks and 12 weeks after surgery
SF-12 quality of life scale
Time Frame: 2 weeks, 6 weeks and 12 weeks after surgery
SF-12 means the 12-items Short Form Health Survey.Patients' scores were measured at 2,6 and 12 weeks ,and the higher the score ,the better the quality of life.
2 weeks, 6 weeks and 12 weeks after surgery

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.
Peking University Third Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University

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 (Actual)

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.
March 1, 2019

Primary Completion (Actual)

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.
July 1, 2019

Study Completion (Actual)

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.
December 1, 2019

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).
June 25, 2021

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.
July 4, 2021

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.
July 12, 2021

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.
July 12, 2021

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.
July 4, 2021

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.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • M2019069

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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