Treatment AdherenceNCT06070415
Adherence to Exercises for Low Back Pain.
A study testing Chatbot and Education in people with Treatment Adherence and Treatment Compliance, run by University of Valencia at 1 site in Spain.
Trial summary
This project focuses on the effectiveness of a Chatbot in promoting adherence to home physiotherapy treatment for patients with lumbar musculoskeletal injuries. The use of digital technologies and media are an important option to complement in-person treatment and promote adherence to treatment at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Adherence, Treatment Compliance
- What is being tested?
- Chatbot and Education
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 20 Sep 2023to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years.
- Diagnosis of lumbar pain.
- Indication of treatment through home exercises.
- With a personal smartphone
- Verbally confirms to have installed an instant messaging service or app, and accesses it at least 3 times a week
Who cannot join
- No to sign the informed consent.
- Not able to understand, read and write in the Spanish language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adherence to Home Treatment of Patients With Low Back Pain Through the Use of Information and Communication Technologies.
This project focuses on the effectiveness of a Chatbot in promoting adherence to home physiotherapy treatment for patients with lumbar musculoskeletal injuries. The use of digital technologies and media are an important option to complement in-person treatment and promote adherence to treatment at home. The research aims to verify whether the use of a Chatbot as a means of communication can produce improvements in patient adherence and clinical results.
Read the detailed description
Currently, performing therapeutic exercises in the treatment of musculoskeletal injuries of the spine is decisive in many cases to achieve an improvement in the symptoms of these pathologies, both in the patient's functionality and in the patient's evaluation of their pain. These types of exercises provide improvement, whether they are outpatient or at home. Due to the paradigm shift that has occurred in recent years, mainly motivated by limited resources and the COVID-19 pandemic, it is necessary to complement in-person exercise and/or teaching sessions with homework whenever possible. In addition, unnecessary travel is avoided in case patients live far from the consultation.
Adherence to treatment is crucial to obtain the desired benefits. According to the WHO (2003), adherence is the degree to which a person's behavior corresponds to the recommendations agreed upon by a healthcare professional, and it has been observed that patients who comply may have a better outcome at the end of treatment. However, not meeting a minimum of more than 65% adherence negatively influences the outcome of the patient's recovery, with probable consequences on socio-health costs.
Before the appearance of new technologies, home-type therapeutic exercises were taught in consultation and given to the patient in paper format. Nowadays, the use of information and communication technologies (ICT) and digital media are an option when administering home treatments, and thanks to these we have much more complete teaching materials. when it comes to remembering what was learned in consultation, such as the Chatbot. For this reason, we value the possibility that the use of this system can help increase adherence to treatment and therefore improve your health condition.
On the other hand, non-compliance rates with treatment are one of the main barriers when it comes to obtaining benefits for the patient. Therefore, digital applications in physiotherapy should be aimed at improving clinical outcomes and promoting adherence through interactive and accessible environments that promote self-efficacy and changes in behavior and routines, as offered by the Chatbot program. One of the most common forms of ICT use is through the use of smartphones, where half of the users of these devices use them to obtain information about health issues, and a fifth uses applications related to this area. This has expanded the offer of health-oriented mobile applications but very little research has been carried out to evaluate adherence or the level of satisfaction among users.
- Conditions
- Treatment Adherence, Treatment Compliance
- Being tested
- Chatbot, Home exercise, usual care, Education
- Keywords
- Treatment adherence, New technologies, Lowback pain
- Medical subject headings
- Treatment Adherence and Compliance, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChatbotDevice
12 week- intervention consisting of messages with an explanatory video of each exercise indicating how to do it and how many repetitions to perform
Home exercise, usual careOther
12 week- intervention. Printed sheets indicating how to exercises and how many repetitions to perform
EducationOther
One-week, three sessions in alternate days, outpatient supervised education on how to perform the exercises at home
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Home exercise assisted with a chatbot Receives: Device: Chatbot; Other: Education |
| Control | Active comparator | Home exercise, usual care Receives: Other: Home exercise, usual care; Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Record of the number of sessions performed.
Measured: 0 weeks, 12 weeks
Secondary outcomes (4)
Visual analogue scale (VAS)
Numerical scale from 0 to 10, where 0 indicates no pain and 10 is the maximum pain experienced.
Measured: 0 weeks, 12 weeks
Disability
The Oswetry Disability Index (ODI) scale, each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Measured: 0 weeks, 12 weeks
Satisfaction scale with the treatment received
The CRES-4 satisfaction scale consists of four items designed to evaluate whether patients are satisfied with the therapy they have received and whether it has been perceived as effective. Its global score is intended to reflect treatment effectiveness as perceived by the patient. It is a good complementary tool to judge, in particular, satisfaction with the treatment received. Consists of four questions, and score with a score ranging from 0 to 18 points. The more points, the more satisfied you are with the treatment.
Measured: 12 weeks
Sistem usability scale
It consists of a 10 item questionnaire for measuring the usability of the experimental intervention tool with five response options for respondents, from Strongly agree to Strongly disagree
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start20 Sep 2023
- Primary completion20 May 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arms study, experimental vs control
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Hernández-Guillén, University of Valencia
- Investigators
- David Hernández-Guillén, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070415
- Sponsor's protocol ID
- CHATBOT_LOW_BACK_PAIN
- Status last verified
- Nov 2024
- First submitted
- 29 Sep 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Home Treatment of Patients With Low Back Pain Through the Use of Information and Communication Technologies.
- ClinicalTrials.gov ID
- NCT06070415
- Acronym / sponsor ID
- CHATBOT_LOW_BACK_PAIN
- Conditions
- Treatment Adherence, Treatment Compliance
- Keywords
- Treatment adherence, New technologies, Lowback pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project focuses on the effectiveness of a Chatbot in promoting adherence to home physiotherapy treatment for patients with lumbar musculoskeletal injuries. The use of digital technologies and media are an important option to complement in-person treatment and promote adherence to treatment at home. The research aims to verify whether the use of a Chatbot as a means of communication can produce improvements in patient adherence and clinical results.
Detailed description
Currently, performing therapeutic exercises in the treatment of musculoskeletal injuries of the spine is decisive in many cases to achieve an improvement in the symptoms of these pathologies, both in the patient's functionality and in the patient's evaluation of their pain. These types of exercises provide improvement, whether they are outpatient or at home. Due to the paradigm shift that has occurred in recent years, mainly motivated by limited resources and the COVID-19 pandemic, it is necessary to complement in-person exercise and/or teaching sessions with homework whenever possible. In addition, unnecessary travel is avoided in case patients live far from the consultation.
Adherence to treatment is crucial to obtain the desired benefits. According to the WHO (2003), adherence is the degree to which a person's behavior corresponds to the recommendations agreed upon by a healthcare professional, and it has been observed that patients who comply may have a better outcome at the end of treatment. However, not meeting a minimum of more than 65% adherence negatively influences the outcome of the patient's recovery, with probable consequences on socio-health costs.
Before the appearance of new technologies, home-type therapeutic exercises were taught in consultation and given to the patient in paper format. Nowadays, the use of information and communication technologies (ICT) and digital media are an option when administering home treatments, and thanks to these we have much more complete teaching materials. when it comes to remembering what was learned in consultation, such as the Chatbot. For this reason, we value the possibility that the use of this system can help increase adherence to treatment and therefore improve your health condition.
On the other hand, non-compliance rates with treatment are one of the main barriers when it comes to obtaining benefits for the patient. Therefore, digital applications in physiotherapy should be aimed at improving clinical outcomes and promoting adherence through interactive and accessible environments that promote self-efficacy and changes in behavior and routines, as offered by the Chatbot program. One of the most common forms of ICT use is through the use of smartphones, where half of the users of these devices use them to obtain information about health issues, and a fifth uses applications related to this area. This has expanded the offer of health-oriented mobile applications but very little research has been carried out to evaluate adherence or the level of satisfaction among users.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two arms study, experimental vs control
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Chatbot, Other: EducationHome exercise assisted with a chatbot |
| Control | Active comparator | Other: Home exercise, usual care, Other: EducationHome exercise, usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years.
- Diagnosis of lumbar pain.
- Indication of treatment through home exercises.
- With a personal smartphone
- Verbally confirms to have installed an instant messaging service or app, and accesses it at least 3 times a week
Key exclusion criteria (2 listed)
- No to sign the informed consent.
- Not able to understand, read and write in the Spanish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chatbot12 week- intervention consisting of messages with an explanatory video of each exercise indicating how to do it and how many repetitions to perform | Device | Experimental |
| Home exercise, usual care12 week- intervention. Printed sheets indicating how to exercises and how many repetitions to perform | Other | Control |
| EducationOne-week, three sessions in alternate days, outpatient supervised education on how to perform the exercises at home | Other | Control, Experimental |
Primary outcome
Adherence
Time frame: 0 weeks, 12 weeks
Record of the number of sessions performed.
4 secondary outcomes
Visual analogue scale (VAS)
Time frame: 0 weeks, 12 weeks
Disability
Time frame: 0 weeks, 12 weeks
Satisfaction scale with the treatment received
Time frame: 12 weeks
Sistem usability scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hernández-Guillén principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chatbot and Education in people with Treatment Adherence and Treatment Compliance, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: 0 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024; AzTrials last refreshed its copy on 29 Oct 2026.