Digital Clinical Diet Registrations AdvantagesNCT04738682
Intervention of Diet Registration Method for Rehabilitation Patients
A study testing Digital dietary registration and Conventional dietary registration in people with Digital Clinical Diet Registrations Advantages and Patients in Rehabilitation, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Study aims to investigate whether dietary registration can be performed with greater precision using digital registration units (mobile devices), rather than conventional paper based dietary registers. Study intervention is based in the M3 rehabilitation unit, as part of Hobro hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digital Clinical Diet Registrations Advantages, Patients in Rehabilitation
- What is being tested?
- Digital dietary registration and Conventional dietary registration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2021to 1 Jul 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
- The patient needs to be admitted to the rehabilitation unit at Hobro Hospital
- The patient need to give consent to be included.
- The patient needs to be admitted to the unit for at least 6 days
- The patient has to have 3 days of diet registration with both methods to be included in the data
- The patient need to be of legal age to give consent
Who cannot join
- The patient mustn be afflicted by any psychological illness, and must be of sound mind, so a normal conversation doesn't pose any problems.
- The patient mustn be sick with Covid-19, or other infectious diseases
- The patient mustn be terminal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Audit and Intervention of Diet Registration Method for Rehabilitation Patients at Hobro Hospital
Study aims to investigate whether dietary registration can be performed with greater precision using digital registration units (mobile devices), rather than conventional paper based dietary registers.
Study intervention is based in the M3 rehabilitation unit, as part of Hobro hospital. The intervention will proceed until 6 full-day dietary registrations have been collected per patient (40 patients total), 3 for each registration method. The estimated time requirement is 30 days.
Read the detailed description
Study aims to investigate whether dietary registration can be performed with greater precision using digital registration units (mobile devices), rather than conventional paper based dietary registers.
These mobile devices have been equipped with a dietary registration app, developed by the company Movesca ApS, specializing in digital healthcare solutions.
Nurses, and other relevant staff members at the M3 rehabilitation unit at Hobro hospital, will be testing this alternative registration method, as they engage in their day-to-day dietary registration for in-house patients. The data collection requires 6 full-day dietary registrations from each individual patient (40 patients in total). Of these 6 registrations, 3 will be gathered using mobile devices and 3 using conventional paper based registers.
The study primary endpoint is precision. The golden standard is dietary recall. The two methods will be assessed in accordance with their uniformity to the dietary recalls, which will be performed by the investigators following the meals.
As a preemptive measure, an internal retrospective audit was performed, with dietary registration as the objective. This audit was completed to retrieve baseline data on dietary registration, and determine whether the rehabilitation unit conforms to the regulations set by the region.
- Being tested
- Digital dietary registration, Conventional dietary registration
- Keywords
- dietary registration, methods for diet registration, comparison of electronic and paper registration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital dietary registrationOther
Also called Dietary registration app supplied by Movesca ApS, used on cellphones present at the unit
The purpose of the intervention is to test whether digital dietary registration can yield more precise and consistent data, than conventional pen and paper based registration.
Furthermore a subjective evaluation of the use of digital registration will be conducted by the staff upon completion of the intervention. The format will be individual interviews held by the investigators.
Conventional dietary registrationOther
Also called Paper form with all the possbible dietary options for each meal listed.
The conventional way of doing dietary registration. This is done by a paper form, with the dietary options listed. The form is then filled in and logged by staff working in the afternoon.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Digital -> Conventional) | Active comparator | Patients allocated to Group 1 (Digital -> Conventional) will undergo three days of digital dietary registration, using mobile devices, followed by three days of conventional dietary registration, using pen and paper. Receives: Other: Digital dietary registration; Other: Conventional dietary registration |
| Group 2 - (Conventional -> Digital) | Active comparator | Patients allocated to Group 2 - (Conventional -> Digital) will undergo the exact opposite sequence, commencing with three days of conventional dietary registration, using pen and paper, followed by three days of digital dietary registration, using mobile devices. Receives: Other: Digital dietary registration; Other: Conventional dietary registration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registered total kJ ingested compared to total kJ registered using golden standard
Does digital dietary registration yield greater precision than conventional paper based registration, in regards to total kJ?
Measured: 4 weeks
Registered total protein ingested compared to total protein registered using golden standard
Does digital dietary registration yield greater precision than conventional paper based registration, in regards to protein intake?
Measured: 4 weeks
Secondary outcomes (2)
Is an adequate consumption of kJ (>75% of estimated kJ) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Do patients reach a stable nutritional state faster when exposed to digital dietary registration, compared to conventional paper based registration? Stable nutritional state is defined as consuming >75% of estimated kJ need per day. Tracked by comparing the registered consumed kJ of the day, with the estimated daily need
Measured: 4 weeks
Is an adequate consumption of protein (>75% of estimated protein) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Do patients reach a stable nutritional state faster when exposed to digital dietary registration, compared to conventional paper based registration? Stable nutritional state is defined as consuming >75% of estimated protein need per day. Tracked by comparing the registered consumed protein of the day, with the estimated daily need
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start15 Feb 2021
- Primary completion15 Mar 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Clinical Diet Registrations AdvantagesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Modified crossover study model, containing two similar patient groups, exposed to identical diet registration methods, but in opposite sequence. Group 1: 3 days of digital dietary registration using mobile devices, followed by 3 days of conventional paper based dietary registration. Group 2: 3 days of conventional paper based dietary registration, followed by 3 days of digital dietary registration, using mobile devices. Each individual patient acts as his/her own control, with regards to the primary endpoint; precision. However patients are divided into two groups, in order to accommodate the study secondary endpoint; progression of nutritional condition, which is evaluated with regards to the registration method used. This requires two arms, where each arm experiences opposite registration method sequences
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Movesca ApS, Departmen for rehabilitation M3, Hobro Hospital
- Responsible party
- Principal investigator, Jens Rikardt Andersen, University of Copenhagen
- Investigators
- Nicolaj Nørlem, MSc, Principal investigator, University of CopenhagenTed Rasmussen, MSc, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738682
- Sponsor's protocol ID
- AppHobro
- Status last verified
- Nov 2022
- First submitted
- 25 Jan 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audit and Intervention of Diet Registration Method for Rehabilitation Patients at Hobro Hospital
- ClinicalTrials.gov ID
- NCT04738682
- Acronym / sponsor ID
- AppHobro
- Keywords
- dietary registration, methods for diet registration, comparison of electronic and paper registration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Movesca ApS, Departmen for rehabilitation M3, Hobro Hospital
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 4 Feb 2021 (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.
Study aims to investigate whether dietary registration can be performed with greater precision using digital registration units (mobile devices), rather than conventional paper based dietary registers.
Study intervention is based in the M3 rehabilitation unit, as part of Hobro hospital. The intervention will proceed until 6 full-day dietary registrations have been collected per patient (40 patients total), 3 for each registration method. The estimated time requirement is 30 days.
Detailed description
Study aims to investigate whether dietary registration can be performed with greater precision using digital registration units (mobile devices), rather than conventional paper based dietary registers.
These mobile devices have been equipped with a dietary registration app, developed by the company Movesca ApS, specializing in digital healthcare solutions.
Nurses, and other relevant staff members at the M3 rehabilitation unit at Hobro hospital, will be testing this alternative registration method, as they engage in their day-to-day dietary registration for in-house patients. The data collection requires 6 full-day dietary registrations from each individual patient (40 patients in total). Of these 6 registrations, 3 will be gathered using mobile devices and 3 using conventional paper based registers.
The study primary endpoint is precision. The golden standard is dietary recall. The two methods will be assessed in accordance with their uniformity to the dietary recalls, which will be performed by the investigators following the meals.
As a preemptive measure, an internal retrospective audit was performed, with dietary registration as the objective. This audit was completed to retrieve baseline data on dietary registration, and determine whether the rehabilitation unit conforms to the regulations set by the region.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Modified crossover study model, containing two similar patient groups, exposed to identical diet registration methods, but in opposite sequence. Group 1: 3 days of digital dietary registration using mobile devices, followed by 3 days of conventional paper based dietary registration. Group 2: 3 days of conventional paper based dietary registration, followed by 3 days of digital dietary registration, using mobile devices. Each individual patient acts as his/her own control, with regards to the primary endpoint; precision. However patients are divided into two groups, in order to accommodate the study secondary endpoint; progression of nutritional condition, which is evaluated with regards to the registration method used. This requires two arms, where each arm experiences opposite registration method sequences
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Digital -> Conventional) | Active comparator | Other: Digital dietary registration, Other: Conventional dietary registrationPatients allocated to Group 1 (Digital -> Conventional) will undergo three days of digital dietary registration, using mobile devices, followed by three days of conventional dietary registration, using pen and paper. |
| Group 2 - (Conventional -> Digital) | Active comparator | Other: Digital dietary registration, Other: Conventional dietary registrationPatients allocated to Group 2 - (Conventional -> Digital) will undergo the exact opposite sequence, commencing with three days of conventional dietary registration, using pen and paper, followed by three days of digital dietary registration, using mobile devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient needs to be admitted to the rehabilitation unit at Hobro Hospital
- The patient need to give consent to be included.
- The patient needs to be admitted to the unit for at least 6 days
- The patient has to have 3 days of diet registration with both methods to be included in the data
- The patient need to be of legal age to give consent
Key exclusion criteria (3 listed)
- The patient mustn be afflicted by any psychological illness, and must be of sound mind, so a normal conversation doesn't pose any problems.
- The patient mustn be sick with Covid-19, or other infectious diseases
- The patient mustn be terminal
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 |
|---|---|---|
| Digital dietary registrationAlso: Dietary registration app supplied by Movesca ApS, used on cellphones present at the unitThe purpose of the intervention is to test whether digital dietary registration can yield more precise and consistent data, than conventional pen and paper based registration. Furthermore a subjective evaluation of the use of digital registration will be conducted by the staff upon completion of the intervention. The format will be individual interviews held by the investigators. | Other | Group 1 (Digital -> Conventional), Group 2 - (Conventional -> Digital) |
| Conventional dietary registrationAlso: Paper form with all the possbible dietary options for each meal listed.The conventional way of doing dietary registration. This is done by a paper form, with the dietary options listed. The form is then filled in and logged by staff working in the afternoon. | Other | Group 1 (Digital -> Conventional), Group 2 - (Conventional -> Digital) |
Primary outcome
Registered total kJ ingested compared to total kJ registered using golden standard
Time frame: 4 weeks
Does digital dietary registration yield greater precision than conventional paper based registration, in regards to total kJ?
Registered total protein ingested compared to total protein registered using golden standard
Time frame: 4 weeks
Does digital dietary registration yield greater precision than conventional paper based registration, in regards to protein intake?
2 secondary outcomes
Is an adequate consumption of kJ (>75% of estimated kJ) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Time frame: 4 weeks
Is an adequate consumption of protein (>75% of estimated protein) achieved in fewer days with the digital dietary registration, than the conventional dietary registration
Time frame: 4 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 4 Nov 2022.
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.
Nicolaj Nørlem, MSc principal investigator
University of Copenhagen
Ted Rasmussen, MSc principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital dietary registration and Conventional dietary registration in people with Digital Clinical Diet Registrations Advantages and Patients in Rehabilitation, run by University of Copenhagen 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 5 inclusion and 3 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 4 Nov 2022. 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?
Registered total kJ ingested compared to total kJ registered using golden standard (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 4 Nov 2022.