Rheumatoid ArthritisNCT03486613
PROM Collected Via a Smartphone App Versus a Touch Screen Solution Among Patients With Inflammatory Arthritis
A study testing PROM registration via the DANBIO App on a smartphone and PROM registration via the touch screen solution in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Salome Kristensen at 1 site in Denmark.
Trial summary
A randomised, within-participants cross-over design trial including 60 patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis. The participants will be randomised to data registration of patient reported outcome measures (PROM) through the DANBIO app on a smartphone first and thereafter… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis
- What is being tested?
- PROM registration via the DANBIO App on a smartphone and PROM registration via the touch screen solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Apr 2019to 12 Sep 2019
- 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
- A participant will be eligible for study participation if he/she meets the following criteria:
- Diagnosed in DANBIO with RA, PsA or SpA
- Is currently treated and monitored at the rheumatology outpatient clinic at Aalborg University Hospital
- Have previously reported PROM in DANBIO through the touch screen solution at the rheumatology outpatient clinic ≥ 3 times
Who cannot join
- A participant cannot be included in the study if he/she meets any of the following criteria:
- Inability to provide informed consent or unwilling to comply with the study protocol
- Diagnosis of RA, PsA or SpA ≤ 12 months
- Does not have access to a smartphone that can download and run the DANBIO app
- Not able to understand written Danish i.e. cannot understand the Danish version of the PROM questionnaires
- Reduced sight in such degree that the participant cannot read the questionnaire in the smartphone app/on the touch-screen with e.g. glasses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient-reported Outcome Measures Collected in DANBIO Reported Via a Smartphone App Versus a Touch Screen Solution in an Outpatient Clinic Among Patients With Inflammatory Arthritis: A Randomised Cross-over Agreement Study
A randomised, within-participants cross-over design trial including 60 patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis. The participants will be randomised to data registration of patient reported outcome measures (PROM) through the DANBIO app on a smartphone first and thereafter via the touch screen solution at the rheumatology outpatient clinic or vice versa. Outcomes are the following PROM: HAQ, VAS pain, VAS fatigue, VAS global Health, BASDAI, BASFI, PASS, Anchoring question, DAS28crp and ASDAS.
Read the detailed description
The study is a randomised, within-participants cross-over design trial including 60 patients with rheumatoid arthritis (RA) (20), psoriatic arthritis (PsA) (20) and axial spondyloarthritis (SpA) (20) from the Rheumatology outpatient clinic at Aalborg University Hospital. The participants will be randomised in ratio 1:1 to:
- Group AT (App → Touch) (30 participants) the participant reports data through the DANBIO app on a smartphone first and after a "washout period" of one day via the touch screen solution at the rheumatology outpatient clinic.
- Group TA (Touch → App) (30 participants): the participant reports data through the touch screen solution at the rheumatology outpatient clinic and after a "washout period" of one day via the DANBIO app on a smartphone.
The primary objective is to evaluate whether electronic reporting of PROM through the DANBIO smartphone app is comparable to the traditional touch screen solution in the rheumatology outpatient clinic among patients with inflammatory arthritis in standard clinical care. The primary outcome is HAQ. Secondary outcomes are: VAS pain, VAS fatigue, VAS global Health, BASDAI, BASFI, PASS, Anchoring question, DAS28crp and ASDAS. DAS28crp are estimated using a fixed level for C-reactive protein (CRP) level of 6, swollen joint count of 0.5 and tender joint count of 1. ASDAS are estimated using a fixed level for CRP of 6. These data are based on DANBIO registrations of patients with RA, PsA or SpA from the rheumatology outpatient clinic at Aalborg University Hospital. DAS28crp and ASDAS are estimated from the PROM data to give the clinician an overview of PROM correlating to e.g. remission or high disease activity.
- Being tested
- PROM registration via the DANBIO App on a smartphone, PROM registration via the touch screen solution
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROM registration via the DANBIO App on a smartphoneOther
PROM data is reported through the DANBIO smartphone app
PROM registration via the touch screen solutionOther
PROM data is reported through the touch screen solution
| Study group | Role | What they receive |
|---|---|---|
| Group AT | Other | PROM registration via the DANBIO App on a smartphone and thereafter the touch screen solution Receives: Other: PROM registration via the DANBIO App on a smartphone; Other: PROM registration via the touch screen solution |
| Group TA | Other | PROM registration via the touch screen solution and thereafter the DANBIO App Receives: Other: PROM registration via the DANBIO App on a smartphone; Other: PROM registration via the touch screen solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Assessment Questionnaire (HAQ)
Assess the patient's physical function
Measured: day 1 (first data registration) and day 3 (second data registration)
Secondary outcomes (9)
Visual Analogue Scale for Pain
The patient's assessment of pain on a scale from 0-100 within the last week. The left of the scale (0) signifies the absence of pain and the right end (100) maximum pain.
Measured: day 1 (first data registration) and day 3 (second data registration)
Visual Analogue Scale for fatigue
The patient's assessment of fatigue on a scale from 0-100 within the last week. The left of the scale (0) signifies the absence of fatigue and the right end (100) maximum fatigue.
Measured: day 1 (first data registration) and day 3 (second data registration)
Patient Global Visual Analogue Scale
The patient's global assessment of disease activity (arthritis severity) on a scale from 0-100 within the last week. The left of the scale (0) signifies the absence of arthritis activity and the right end (100) maximum arthritis activity.
Measured: day 1 (first data registration) and day 3 (second data registration)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The patient's assessment of essential symptoms in axial arthritis. The questionnaire consist of six questions regarding essential symptoms in axial arthritis answered on a Visual Analogue Scale from 0-100. The left of the scale (0) signifies the absence of symptoms and the right end (100) maximum symptoms. The patient's answer for each individual question are added to a combined score of 0-100, where 0 signifies the absence of symptoms and 100 maximum symptoms.
Measured: day 1 (first data registration) and day 3 (second data registration)
Bath Ankylosing Spondylitis Functional Index (BASFI)
The patient's assesment of physical function. The questionnaire consist of ten questions regarding physical function in axial arthritis answered on a Visual Analogue Scale from 0-100. The left of the scale (0) signifies the absence of physical limitations and the right end (100) maximum physical limitations. The patient's answer for each individual question are added to a combined score of 0-100, where 0 signifies the absence physical limitations and 100 maximum physical limitations.
Measured: day 1 (first data registration) and day 3 (second data registration)
Patient Acceptable Symptom State (PASS)
The patient's assessment of acceptable symptom state. Consist of one question answered with "yes" or "no". The question is: ''Take into account all the ways in which your arthritis has affected you in the past 48 hours. If you were to remain for the next few months as you are today, would it be acceptable to you?"
Measured: day 1 (first data registration) and day 3 (second data registration)
Anchoring question
The patient's assessment of change in arthritis activity since last visit
Measured: day 1 (first data registration) and day 3 (second data registration)
Disease Activity Score 28 joints C-reactive protein (DAS28crp)
Composite score used as a measurement of disease activity in patients with peripheral arthritis. The DAS28crp score is based on 28 joint count for tenderness (TJC28) and swelling (SJC28), Patient Global Visual Analogue Scale (GH) and CRP level (CRP). The DAS28crp equation is: DAS28crp = 0.56square root(TJC28) + 0.28square root(SJC28) + 0.36ln(CRP + 1) + 0.014(GH) + 0.96. ASDAS = 0.12*Back Pain + 0.06*Morning Stiffness + 0.11*Patient Global + 0.07*Peripheral Pain/Swelling + 0.58*Ln(CRP+1)0.96-9.4 where a score under 2.6 is remission, a score between 2.6-3.1 is low disease activity, a score of 3.2-5.1 is moderate disease activity and a score of 5.1 or higher is high disease activity.
Measured: day 1 (first data registration) and day 3 (second data registration)
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Composite score used as a measurement of disease activity in patients with axial arthritis. The ASDAS score is based on some of the questions from the BASDAI questionnaire and C-reative protein (CRP). The ASDAS equation is: ASDAS = 0.12*Back Pain + 0.06*Morning Stiffness + 0.11*Patient Global + 0.07*Peripheral Pain/Swelling + 0.58*Ln(CRP+1). The scale ranges from 0.6 to infinite where a score under 1.3 is remission, a score between 1.3-2.0 is moderate disease activity, a score of 2.1-3.5 is high disease activity and a score of higher than 3.5 is very high disease activity.
Measured: day 1 (first data registration) and day 3 (second data registration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start24 Apr 2019
- Primary completion12 Sep 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Crossover
- Model description
- A randomised, within-participants, open, cross-over design trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salome Kristensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Salome Kristensen, Aalborg University Hospital
- Investigators
- Salome Kristensen, MD, PhD, Principal investigator, Department of Rheumatology, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486613
- Sponsor's protocol ID
- 2018-000367
- Other IDs
- 2018
- Status last verified
- Sep 2019
- First submitted
- 8 Feb 2018
- Last updated
- 2 Oct 2019
- 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 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcome Measures Collected in DANBIO Reported Via a Smartphone App Versus a Touch Screen Solution in an Outpatient Clinic Among Patients With Inflammatory Arthritis: A Randomised Cross-over Agreement Study
- ClinicalTrials.gov ID
- NCT03486613
- Acronym / sponsor ID
- 2018-000367
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Salome KristensenUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 3 Apr 2018 (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.
A randomised, within-participants cross-over design trial including 60 patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis. The participants will be randomised to data registration of patient reported outcome measures (PROM) through the DANBIO app on a smartphone first and thereafter via the touch screen solution at the rheumatology outpatient clinic or vice versa. Outcomes are the following PROM: HAQ, VAS pain, VAS fatigue, VAS global Health, BASDAI, BASFI, PASS, Anchoring question, DAS28crp and ASDAS.
Detailed description
The study is a randomised, within-participants cross-over design trial including 60 patients with rheumatoid arthritis (RA) (20), psoriatic arthritis (PsA) (20) and axial spondyloarthritis (SpA) (20) from the Rheumatology outpatient clinic at Aalborg University Hospital. The participants will be randomised in ratio 1:1 to:
- Group AT (App → Touch) (30 participants) the participant reports data through the DANBIO app on a smartphone first and after a "washout period" of one day via the touch screen solution at the rheumatology outpatient clinic.
- Group TA (Touch → App) (30 participants): the participant reports data through the touch screen solution at the rheumatology outpatient clinic and after a "washout period" of one day via the DANBIO app on a smartphone.
The primary objective is to evaluate whether electronic reporting of PROM through the DANBIO smartphone app is comparable to the traditional touch screen solution in the rheumatology outpatient clinic among patients with inflammatory arthritis in standard clinical care. The primary outcome is HAQ. Secondary outcomes are: VAS pain, VAS fatigue, VAS global Health, BASDAI, BASFI, PASS, Anchoring question, DAS28crp and ASDAS. DAS28crp are estimated using a fixed level for C-reactive protein (CRP) level of 6, swollen joint count of 0.5 and tender joint count of 1. ASDAS are estimated using a fixed level for CRP of 6. These data are based on DANBIO registrations of patients with RA, PsA or SpA from the rheumatology outpatient clinic at Aalborg University Hospital. DAS28crp and ASDAS are estimated from the PROM data to give the clinician an overview of PROM correlating to e.g. remission or high disease activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomised, within-participants, open, cross-over design trial
| Arm | Type | Receives |
|---|---|---|
| Group AT | Other | Other: PROM registration via the DANBIO App on a smartphone, Other: PROM registration via the touch screen solutionPROM registration via the DANBIO App on a smartphone and thereafter the touch screen solution |
| Group TA | Other | Other: PROM registration via the DANBIO App on a smartphone, Other: PROM registration via the touch screen solutionPROM registration via the touch screen solution and thereafter the DANBIO App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A participant will be eligible for study participation if he/she meets the following criteria:
- Diagnosed in DANBIO with RA, PsA or SpA
- Is currently treated and monitored at the rheumatology outpatient clinic at Aalborg University Hospital
- Have previously reported PROM in DANBIO through the touch screen solution at the rheumatology outpatient clinic ≥ 3 times
Key exclusion criteria (6 listed)
- A participant cannot be included in the study if he/she meets any of the following criteria:
- Inability to provide informed consent or unwilling to comply with the study protocol
- Diagnosis of RA, PsA or SpA ≤ 12 months
- Does not have access to a smartphone that can download and run the DANBIO app
- Not able to understand written Danish i.e. cannot understand the Danish version of the PROM questionnaires
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 |
|---|---|---|
| PROM registration via the DANBIO App on a smartphonePROM data is reported through the DANBIO smartphone app | Other | Group AT, Group TA |
| PROM registration via the touch screen solutionPROM data is reported through the touch screen solution | Other | Group AT, Group TA |
Primary outcome
Change in Health Assessment Questionnaire (HAQ)
Time frame: day 1 (first data registration) and day 3 (second data registration)
Assess the patient's physical function
9 secondary outcomes
Visual Analogue Scale for Pain
Time frame: day 1 (first data registration) and day 3 (second data registration)
Visual Analogue Scale for fatigue
Time frame: day 1 (first data registration) and day 3 (second data registration)
Patient Global Visual Analogue Scale
Time frame: day 1 (first data registration) and day 3 (second data registration)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: day 1 (first data registration) and day 3 (second data registration)
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: day 1 (first data registration) and day 3 (second data registration)
Patient Acceptable Symptom State (PASS)
Time frame: day 1 (first data registration) and day 3 (second data registration)
Anchoring question
Time frame: day 1 (first data registration) and day 3 (second data registration)
Disease Activity Score 28 joints C-reactive protein (DAS28crp)
Time frame: day 1 (first data registration) and day 3 (second data registration)
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: day 1 (first data registration) and day 3 (second data registration)
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 2 Oct 2019.
- 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.
Salome Kristensen, MD, PhD principal investigator
Department of Rheumatology, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROM registration via the DANBIO App on a smartphone and PROM registration via the touch screen solution in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by Salome Kristensen at 1 site in Denmark.
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 4 inclusion and 6 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 2 Oct 2019. 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 Denmark. 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?
Change in Health Assessment Questionnaire (HAQ) (time frame: day 1 (first data registration) and day 3 (second data registration)). 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 2 Oct 2019.