EpilepsyNCT05068869
Digital Outpatient Services
A study testing Dignio Digital Remote Care intervention group in people with Epilepsy and Cancer, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
More people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. Seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Cancer, Interstitial Lung Disease
- What is being tested?
- Dignio Digital Remote Care intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesNorway
- Study dates
- 12 Sep 2021to 31 Dec 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
- Patients attending the study centers that are cognitively able to use a digital outpatient service with no major conflicting disorders, with one of the following disorders:
- cancer
- epilepsy
- interstitial lung disease
- long-term complex pain conditions
Who cannot join
- under the age of 18
- any mental or cognitive conditions interfering with their ability to participate
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Oslo University Hospital
Oslo
University Hospital of North Norway
Tromsø
About this study
Official title: Digital Outpatient Services - a Controlled Multicenter Study
More people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. Seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without leading to more patient readmissions. Further, new services should take into account the patients capacity to benefit from the services, and their level of health literacy is crucial. By developing new services using technology, patients will be able to be followed up closely in their own home with adapted treatment and information, a closer dialogue with the health service where there is a need, and the utilization of scarce resources in the health care system can increase.
The aim of the current study is to evaluate a digital outpatient clinic, and assess any differences over time in health literacy, digital health literacy, quality of life and overall satisfaction with the outpatient services. Furthermore, the investigators will assess the intervention group's satisfaction with the digital outpatient clinic. In addition, the digital services will be tailored and revised throughout the study based on continuous feedback and iterative processes.
The current study is a pragmatic controlled multicenter study with two study arms; one control arm and one intervention arm. In total, eligible participants will be recruited from one of four centers.
- Conditions
- Epilepsy, Cancer, Interstitial Lung Disease, Long Term Pain
- Being tested
- Dignio Digital Remote Care intervention group, Usual Care Control group
- Keywords
- Digital outpatient services, Health literacy, mHealth, eHealth, Satisfaction, Controlled trial
- Medical subject headings
- Epilepsy, Neoplasms, Lung Diseases, Interstitial, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dignio Digital Remote Care intervention groupOther
The intervention consists of Dignio Prevent (for healthcare professionals) and MyDignio (for patients). The system is CE marked and the system satisfies all regulatory requirements for privacy and information security. Various components can be added for an individualized follow-up of the patients.
Elements of the digital outpatient service in Dignio include patient reported outcomes and other questionnaires, tasks, objective measures, reminders and information, in addition to a chat function for asynchronous contact with healthcare personnel and video consultations for real-time consultations.
Usual Care Control groupOther
Participants in the control group will receive follow-up at the outpatient clinic as per their needs.
| Study group | Role | What they receive |
|---|---|---|
| Dignio Digital Remote Care intervention group | Other | Participants will receive the MyDignio app for individualized follow-up for 6 months. Receives: Other: Dignio Digital Remote Care intervention group |
| Usual Care Control group | Other | Participants in the control group will receive follow-up at the outpatient clinic as per their needs. Receives: Other: Usual Care Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health literacy
The HLQ is a standardized measure of health literacy, and the investigators will apply five of the nine domains; 1 Feeling understood and supported by healthcare providers; 2 Having sufficient information to manage my health; 3 Actively managing my health; 6 Ability to actively engage with healthcare providers; and 9 Understanding health information well enough to know what to do. the HLQ is is translated and validated in Norwegian.
(Osborne et al. 2013; Wahl et al. 2020)
Measured: Baseline, 3 months, and 6 months follow-up.
Secondary outcomes (4)
Change in Digital health literacy
The investigators will apply the eHLQ to measure level of digital health literacy. The eHLQ contains 35 items summarized in seven domains: 1) using technology to process health information, 2) understanding of health concepts and language, 3) ability to actively engage with digital services, 4) feel safe and in control, 5) motivated to engage with digital services, 6) access to digital services that work, and 7) digital services that suit individual needs. Higher scores indicate better digital health literacy. Domains 1-5 consist of 5 items, domain 6 consists of 6 items, and domain 7 consists of 4 items.
(Kayser et al. 2018)
Measured: Baseline, 3 months, and 6 months months follow-up.
Change in Health/ quality of life
To assess the patient reported health or quality of life the investigators will use the 12-Item Short Form Survey from the RAND Medical Outcomes Study (RAND-12) (Ware et al. 1996). The items summarizes into two scales; mental component score and Physical component score. Higher scores indicate better health, and the instruments is translated and validated in Norwegian.
Measured: Baseline, 3 months, and 6 months follow-up.
Change in Perceived safety in a pandemic
To assess the participants self-perceived safety in the pandemic the investigators will apply the item: "How anxious are you to be infected with Covid-19 (corona)?" with responses on a 5 point Likert scale from "Not anxious" to "Very anxious" .
Measured: Baseline, 3 months, and 6 months follow-up.
Change in Satisfaction with digital services
The Service User Technology Acceptability Questionnaire (SUTAQ) is an instrument that can be used to measure user beliefs about the acceptability of digital services, and has the ability to discriminate and predict individual differences in beliefs and behaviour.
(Hirani et al 2016; Torbjørnsen et al. 2018)
Measured: 3 months, and 6 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start12 Sep 2021
- Primary completion1 Jul 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway
- Responsible party
- Principal investigator, Heidi Holmen, Oslo University Hospital
- Investigators
- Erik Fosse, PhD, Study director, Oslo University HospitalHeidi Holmen, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068869
- Sponsor's protocol ID
- 21/06826
- Status last verified
- Nov 2023
- First submitted
- 19 Sep 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmen H, Fosse E. "I Want to Spend My Time Living"-Experiences With a Digital Outpatient Service With a Mobile App for Tailored Care Among Adults With Long-Term Health Service Needs: Qualitative Study Using Thematic Analysis. J Med Internet Res. 2026 Jan 15;28:e79155. doi: 10.2196/79155.
PubMed 41538795Holmen H, Holm AM, Falk RS, Kilvaer TK, Ljosaa TM, Ekholdt C, Fosse E. A Digital Outpatient Service With a Mobile App for Tailored Care and Health Literacy in Adults With Long-Term Health Service Needs: Multicenter Nonrandomized Controlled Trial. J Med Internet Res. 2025 Apr 28;27:e60343. doi: 10.2196/60343.
PubMed 40294411Holmen H, Holm AM, Kilvaer TK, Ljosa TM, Granan LP, Ekholdt C, Larsen LS, Fosse E. Digital Outpatient Services for Adults: Development of an Intervention and Protocol for a Multicenter Non-Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 10;12:e46649. doi: 10.2196/46649.
PubMed 37428533
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Outpatient Services - a Controlled Multicenter Study
- ClinicalTrials.gov ID
- NCT05068869
- Acronym / sponsor ID
- 21/06826
- Conditions
- Epilepsy, Cancer, Interstitial Lung Disease, Long Term Pain
- Keywords
- Digital outpatient services, Health literacy, mHealth, eHealth, Satisfaction, Controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital of North Norway
- Study start
- 12 Sep 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Oct 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.
More people are living with chronic or long-term disorders together and they live longer, which gives an increase in patients who need health services. Seen in the context of the shorter lengths of stay, and the outpatient clinics' increasing responsibility, there is a need to increase outpatient capacity without leading to more patient readmissions. Further, new services should take into account the patients capacity to benefit from the services, and their level of health literacy is crucial. By developing new services using technology, patients will be able to be followed up closely in their own home with adapted treatment and information, a closer dialogue with the health service where there is a need, and the utilization of scarce resources in the health care system can increase.
The aim of the current study is to evaluate a digital outpatient clinic, and assess any differences over time in health literacy, digital health literacy, quality of life and overall satisfaction with the outpatient services. Furthermore, the investigators will assess the intervention group's satisfaction with the digital outpatient clinic. In addition, the digital services will be tailored and revised throughout the study based on continuous feedback and iterative processes.
The current study is a pragmatic controlled multicenter study with two study arms; one control arm and one intervention arm. In total, eligible participants will be recruited from one of four centers.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dignio Digital Remote Care intervention group | Other | Other: Dignio Digital Remote Care intervention groupParticipants will receive the MyDignio app for individualized follow-up for 6 months. |
| Usual Care Control group | Other | Other: Usual Care Control groupParticipants in the control group will receive follow-up at the outpatient clinic as per their needs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients attending the study centers that are cognitively able to use a digital outpatient service with no major conflicting disorders, with one of the following disorders:
- cancer
- epilepsy
- interstitial lung disease
- long-term complex pain conditions
Key exclusion criteria (2 listed)
- under the age of 18
- any mental or cognitive conditions interfering with their ability to participate
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 |
|---|---|---|
| Dignio Digital Remote Care intervention groupThe intervention consists of Dignio Prevent (for healthcare professionals) and MyDignio (for patients). The system is CE marked and the system satisfies all regulatory requirements for privacy and information security. Various components can be added for an individualized follow-up of the patients. Elements of the digital outpatient service in Dignio include patient reported outcomes and other questionnaires, tasks, objective measures, reminders and information, in addition to a chat function for asynchronous contact with healthcare personnel and video consultations for real-time consultations. | Other | Dignio Digital Remote Care intervention group |
| Usual Care Control groupParticipants in the control group will receive follow-up at the outpatient clinic as per their needs. | Other | Usual Care Control group |
Primary outcome
Change in Health literacy
Time frame: Baseline, 3 months, and 6 months follow-up.
The HLQ is a standardized measure of health literacy, and the investigators will apply five of the nine domains; 1 Feeling understood and supported by healthcare providers; 2 Having sufficient information to manage my health; 3 Actively managing my health; 6 Ability to actively engage with healthcare providers; and 9 Understanding health information well enough to know what to do. the HLQ is is translated and validated in Norwegian. (Osborne et al. 2013; Wahl et al. 2020)
4 secondary outcomes
Change in Digital health literacy
Time frame: Baseline, 3 months, and 6 months months follow-up.
Change in Health/ quality of life
Time frame: Baseline, 3 months, and 6 months follow-up.
Change in Perceived safety in a pandemic
Time frame: Baseline, 3 months, and 6 months follow-up.
Change in Satisfaction with digital services
Time frame: 3 months, and 6 months follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 41538795Holmen H, Fosse E. "I Want to Spend My Time Living"-Experiences With a Digital Outpatient Service With a Mobile App for Tailored Care Among Adults With Long-Term Health Service Needs: Qualitative Study Using Thematic Analysis. J Med Internet Res. 2026 Jan 15;28:e79155. doi: 10.2196/79155.
- Derived from this study: PubMed 40294411Holmen H, Holm AM, Falk RS, Kilvaer TK, Ljosaa TM, Ekholdt C, Fosse E. A Digital Outpatient Service With a Mobile App for Tailored Care and Health Literacy in Adults With Long-Term Health Service Needs: Multicenter Nonrandomized Controlled Trial. J Med Internet Res. 2025 Apr 28;27:e60343. doi: 10.2196/60343.
- Derived from this study: PubMed 37428533Holmen H, Holm AM, Kilvaer TK, Ljosa TM, Granan LP, Ekholdt C, Larsen LS, Fosse E. Digital Outpatient Services for Adults: Development of an Intervention and Protocol for a Multicenter Non-Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 10;12:e46649. doi: 10.2196/46649.
- 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.
Erik Fosse, PhD study director
Oslo University Hospital
Heidi Holmen principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dignio Digital Remote Care intervention group in people with Epilepsy and Cancer, run by Oslo University Hospital at 2 sites in Norway.
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: status not confirmed, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Results are not available in the source record.
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 literacy (time frame: Baseline, 3 months, and 6 months follow-up.). 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 NCT05068869, which also lists 3 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 1 Dec 2023; AzTrials last refreshed its copy on 29 Oct 2026.