Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization

January 30, 2024 updated by: Ariel University

Can the Enhanced Transtheoretical Model Intervention (ETMI) be Implemented in a Public Health Organization- an Implementation Study

The aim of this study is to assess whether the ETMI method can be implemented among primary care practitioners in the central district of Maccabi Health Services and examine whether it provides a medical and economic advantage.

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

An implementation study- a prospective cohort study with pre- and post-intervention by retrieving economic and therapeutic outcome data from MHS databases. The intervention group will be the Central District of MHS, among 220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment. We will investigate the relationship between the care received and outcomes in terms of healthcare utilization, costs, and patient-relevant outcomes.

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.
Observational

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.
1463

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Israel
      • Ariel, Israel, 40700
        • Ariel University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

220 primary care practitioners (100 Physicians and 120 physiotherapists) and their patients (n=7,000) who suffer from back pain and receive treatment.

Description

Inclusion Criteria:

  • primary care practitioners and their patients, who suffer from back pain and receive treatment.
  • patients who suffer from back pain and receive treatment with or without leg radiation

Exclusion Criteria:

  • no

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Central District
The ETMI method will be implemented in this group
Other: the Enhanced Transtheoretical Model Intervention (ETMI)

ETMI consists of a physical and functional examination, a discussion about the role of physical activity matched to the patient stage of change, and guided through motivational interviewing techniques, exposure to fast walking, and goal setting. The patient receives a postcard outlining the main messages about physical activity and four simple stretches.

The ETMI method consists of four parts:

  1. Creating a therapeutic alliance (communication skills and reassurance)
  2. Clear messages to the patient: Mandatory 3 sentences: (1." physical activity is the only thing that will help your back pain over time." 2. "It's easy to reduce your pain now - but the important thing is to prevent the next episode"," 3. "Your body must be strong and flexible.")
  3. Exposure to brisk walking (brisk walking in the corridor, hand by hand with the therapist) and graded activity.
  4. Postcard with reminder messages on how to self manage the back.
North District
control
Hasharon District
control
South District
control
Jerusalem and Hasfhela District
control

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
ETMI Code
Time Frame: baseline
baseline

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
Lumbar Computerized Adaptive Test (LCAT)
Time Frame: baseline
LCAT is a computerized adaptive test, meaning that the administration selects items from the item bank one at a time based on an administrative algorithm. The final calculated functional score ranges on a linear scale of 0-100, higher measures representing higher function. Additionally, the system predicts a risk-adjusted functional score at discharge. The adjusting is on: functional score at admission, age, sex, chronicity as number of days from onset of the treated condition, number of related surgeries, exercise history and use of medication to treat LBP.MCID for the LCAT is 3-9 points depending on the first score. LCAT has been tested for validity by comparing it to the Oswestry Low Back Pain Disability Questionnaire and has a high level of reliability in the English version (α = 0.92).Several studies have been published using the LCAT's Hebrew version.
baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Economic variables and therapeutic results
Time Frame: baseline
Number of primary care clinician appointments
baseline
Numeric Pain Rate Scale (NPRS)
Time Frame: baseline
The patient is asked to rate his pain intensity in the last 24 hours on a scale of 0-10 (10=severest pain)
baseline
Fear Avoidance Belief Questionnaire (FABQ)
Time Frame: baseline
It is a modification to the original version, allowing for the assessment using an Item Response Theory-based measures replacing the summative methods. The later version consists of three items, scoring 0-100, with 100 representing higher fear-avoidance, and 44 being a cut-off point between high and low values
baseline
Economic variables and therapeutic results
Time Frame: baseline
Number of orthopedic clinician appointments
baseline
Economic variables and therapeutic results
Time Frame: baseline
Number of physiotherapy appointments
baseline
Economic variables and therapeutic results
Time Frame: baseline
Anti-inflammatory drug dosage
baseline
Economic variables and therapeutic results
Time Frame: baseline
Number of imaging tests
baseline
Economic variables and therapeutic results
Time Frame: baseline
Number of surgeries and procedures
baseline

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.
Ariel University

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.
Maccabi Healthcare Services, Israel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ron Feldman, PhD Candidate, Ariel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
January 1, 2022

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.
August 30, 2023

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.
January 2, 2024

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).
March 18, 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.
March 25, 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.
March 26, 2021

Study Record Updates

Last Update Posted (Estimated)

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.
January 31, 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.
January 30, 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.
January 1, 2023

More Information

Terms related to this study

Keywords

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.
  • ArielURF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

the result of the study will be analyzed. a paper will be submitted to an international journal with study description including methods, examination protocol results.

IPD Sharing Time Frame

one year following completion of study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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