Low Back PainNCT03088774
Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website
A study testing Information material in people with Low Back Pain, run by Aalborg University Hospital.
Trial summary
This project studies the effects of involving patients in the development of a web-application. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Information material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2021to 25 Jan 2021
- 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
- Contacting general practice with low back pain
Who cannot join
- Spinal stenosis
- Spine fractures
- Cauda equina syndrome
- Spinal malignancy
- Osteoporosis
- Spondyloarthritis
Show all 9Show fewer
- Without Danish reading skills
- Without internet access
- Pregnant women
About this study
Official title: Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website for Patients With Low Back Pain: a Study Protocol of a Randomised Controlled Trial
This project studies the effects of involving patients in the development of a web-application.
Read the detailed description
The point-prevalence of low back pain (LBP) has been estimated to 9.4 % and LBP is in many countries the most frequent reason to consult a general practitioner. However, general practitioners are under pressure with increasing workloads. The increasing number of patients and the typical 10-15 minutes of available time for each patient are challenging the provision of sufficient information and advice. According to international guidelines information and advice are recommended for every patient with LBP, therefore, new methods to support general practitioners (GPs) are very much needed. Online technologies give new opportunities to extend the treatment. Furthermore, involving patients with LBP in the development of online information material may produce more user friendly content and design and thereby increasing patients' acceptance and usage. Thus, optimizing clinical outcome. This project will study patients' satisfaction and clinical outcomes of a web-application for patients with LBP consulted in general practice compared to best existing technology (the Patient Handbook).
- Conditions
- Low Back Pain
- Being tested
- Information material
- Keywords
- Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information materialOther
Online web-application developed together with patients with low back pain
| Study group | Role | What they receive |
|---|---|---|
| New web-application | Experimental | Information material developed in a participatory design together with patients. Receives: Other: Information material |
| Patient Handbook | Experimental | Public available information. Receives: Other: Information material |
What is being measured
The primary outcome is the main question the study is designed to answer.
General satisfaction
The question: 'how likely is it that you would recommend this web-application to a friend or colleague?' will be applied to measure satisfaction. The patients will be asked to choose between 11 boxes displayed on a horizontal line (10-0 Points, higher score indicating more satisfaction). The scales will be labelled to the left at 10 (extremely likely) and at the right side as 0 (not at all likely). It is only possible to tick off one box, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Responses of 10-9 are grouped as 'satisfied' of the web-application and patients replying 8-0 will be grouped as 'not satisfied'. The proportion of patients being satisfied after 12 weeks is the primary analysis. The proportion of patients being satisfied after 1, 2, 4, and 8 weeks will be carried out as secondary analyses.
Measured: 12 weeks
Secondary outcomes (11)
Functional improvement
Roland Morris functional disability score (RMDQ, the Patrick version, 0-23 points)
Measured: 12 weeks
Pain intensity
Numerical pain rating of current pain (0-10 Points, rating from 'no pain' to 'maximal pain' )
Measured: 1, 2, 4, 8, and 12 weeks
Improvement in self-rated health
EQ-5D-5L (EuroQol - 5 Diminsions - 5 Levels)
Measured: 12 weeks
Employment status
Self reported current employment status (yes/no)
Measured: 12 weeks
Sick leave
Self reported number of hours of sick leave during the study
Measured: 12 weeks
Contacts to general practice
Self reported number of general practice contacts since study inclusion
Measured: 12 weeks
Contacts to primary care physiotherapists
Self reported number of physiotherapy contacts since study inclusion
Measured: 12 weeks
Contacts to primary care chiropractors
Self reported number of chiropractor contacts since study inclusion
Measured: 12 weeks
Contacts to secondary care
Contact to secondary care because of low back pain during the study (yes/no)
Measured: 12 weeks
Cost utility analysis
A analysis comparing the intervention group with the control group from a healthcare perspective. Including primary care costs such as public paid costs for GP contacts, physiotherapy services, and chiropractic services. Quality adjusted life years (QALYs) will be applied as measure of effect based on EQ-5D-5L. We will not include costs for developing and maintaining the new technology or other protocol driven costs. Based on the relative short time-horizon costs and effects will not be discounted.
Measured: 12 weeks
Specific satisfaction
For further exploration of reasons for the primary outcome we include a question regarding the general satisfaction with the web-application (10-0) and detailed questions/items regarding satisfaction with design (very, some, little, none), satisfaction with customisation (very, some, little, none ), satisfaction with usability (very, some, little, none ), satisfaction with readability (very, some, little, none), and satisfaction with credibility (very, some, little, none). It is only possible to tick off one box to each item, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Furthermore, these items will be validated against the primary outcome.
Measured: 1, 2, 4, 8, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start25 Jan 2021
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Why it stopped: The primary trial was stopped. Since, a feasibility study showed that recruitment was not feasible. We obtain a recruitment rate of 15 %.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation of patients 1:1 to the new web-application or to Patient's Handbook
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation, The Danish Rheumatism Association
- Responsible party
- Principal investigator, Allan Riis, Aalborg University Hospital
- Investigators
- Allan Riis, PhD, Principal investigator, Research unit for General Practice in Aalborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088774
- Sponsor's protocol ID
- AllanRiis_4
- Status last verified
- Jan 2021
- First submitted
- 17 Mar 2017
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Riis A, Rathleff MS, Hartvigsen J, Thomsen JL, Afzali T, Jensen MB. Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial). BMC Res Notes. 2020 Jan 10;13(1):24. doi: 10.1186/s13104-020-4894-8.
PubMed 31924258Riis A, Hartvigsen J, Rathleff MS, Afzali T, Jensen MB. Comparing satisfaction with a participatory driven web-application and a standard website for patients with low back pain: a study protocol for a randomised controlled trial (part of the ADVIN Back Trial). Trials. 2018 Jul 25;19(1):399. doi: 10.1186/s13063-018-2795-0.
PubMed 30045749
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Satisfaction With a Participatory Driven Web-application and a Standard Website for Patients With Low Back Pain: a Study Protocol of a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03088774
- Acronym / sponsor ID
- AllanRiis_4
- Conditions
- Low Back Pain
- Keywords
- Low back pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The primary trial was stopped. Since, a feasibility study showed that recruitment was not feasible. We obtain a recruitment rate of 15 %.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation, The Danish Rheumatism Association
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 23 Mar 2017 (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 studies the effects of involving patients in the development of a web-application.
Detailed description
The point-prevalence of low back pain (LBP) has been estimated to 9.4 % and LBP is in many countries the most frequent reason to consult a general practitioner. However, general practitioners are under pressure with increasing workloads. The increasing number of patients and the typical 10-15 minutes of available time for each patient are challenging the provision of sufficient information and advice. According to international guidelines information and advice are recommended for every patient with LBP, therefore, new methods to support general practitioners (GPs) are very much needed. Online technologies give new opportunities to extend the treatment. Furthermore, involving patients with LBP in the development of online information material may produce more user friendly content and design and thereby increasing patients' acceptance and usage. Thus, optimizing clinical outcome. This project will study patients' satisfaction and clinical outcomes of a web-application for patients with LBP consulted in general practice compared to best existing technology (the Patient Handbook).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation of patients 1:1 to the new web-application or to Patient's Handbook
| Arm | Type | Receives |
|---|---|---|
| New web-application | Experimental | Other: Information materialInformation material developed in a participatory design together with patients. |
| Patient Handbook | Experimental | Other: Information materialPublic available information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Contacting general practice with low back pain
Key exclusion criteria (9 listed)
- Spinal stenosis
- Spine fractures
- Cauda equina syndrome
- Spinal malignancy
- Osteoporosis
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 |
|---|---|---|
| Information materialOnline web-application developed together with patients with low back pain | Other | New web-application, Patient Handbook |
Primary outcome
General satisfaction
Time frame: 12 weeks
The question: 'how likely is it that you would recommend this web-application to a friend or colleague?' will be applied to measure satisfaction. The patients will be asked to choose between 11 boxes displayed on a horizontal line (10-0 Points, higher score indicating more satisfaction). The scales will be labelled to the left at 10 (extremely likely) and at the right side as 0 (not at all likely). It is only possible to tick off one box, if the patient change decision while filling in the online questionnaire, another box can be ticked off and the first choice will automatically delete. Responses of 10-9 are grouped as 'satisfied' of the web-application and patients replying 8-0 will be grouped as 'not satisfied'. The proportion of patients being satisfied after 12 weeks is the primary analysis. The proportion of patients being satisfied after 1, 2, 4, and 8 weeks will be carried out as secondary analyses.
11 secondary outcomes
Functional improvement
Time frame: 12 weeks
Pain intensity
Time frame: 1, 2, 4, 8, and 12 weeks
Improvement in self-rated health
Time frame: 12 weeks
Employment status
Time frame: 12 weeks
Sick leave
Time frame: 12 weeks
Contacts to general practice
Time frame: 12 weeks
Contacts to primary care physiotherapists
Time frame: 12 weeks
Contacts to primary care chiropractors
Time frame: 12 weeks
Contacts to secondary care
Time frame: 12 weeks
Cost utility analysis
Time frame: 12 weeks
Specific satisfaction
Time frame: 1, 2, 4, 8, and 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Derived from this study: PubMed 31924258Riis A, Rathleff MS, Hartvigsen J, Thomsen JL, Afzali T, Jensen MB. Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial). BMC Res Notes. 2020 Jan 10;13(1):24. doi: 10.1186/s13104-020-4894-8.
- Derived from this study: PubMed 30045749Riis A, Hartvigsen J, Rathleff MS, Afzali T, Jensen MB. Comparing satisfaction with a participatory driven web-application and a standard website for patients with low back pain: a study protocol for a randomised controlled trial (part of the ADVIN Back Trial). Trials. 2018 Jul 25;19(1):399. doi: 10.1186/s13063-018-2795-0.
- 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.
Allan Riis, PhD principal investigator
Research unit for General Practice in Aalborg, Denmark
Questions about this trial
What is this clinical trial studying?
A study testing Information material in people with Low Back Pain, run by Aalborg University Hospital.
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 1 inclusion and 9 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: withdrawn, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
General satisfaction (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03088774, which also lists 2 linked publications.
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 27 Jan 2021.