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Digital Outpatient Services

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - under the age of 18.
- any mental or cognitive conditions interfering with their ability to participate

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05068869
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Oslo University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Erik Fosse, PhDHeidi Holmen
Principal Investigator Affiliation Oslo University HospitalOslo University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Norway
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Epilepsy, Cancer, Interstitial Lung Disease, Long Term Pain
Arms & Interventions

Arms

Other: Dignio Digital Remote Care intervention group

Participants will receive the MyDignio app for individualized follow-up for 6 months.

Other: Usual Care Control group

Participants in the control group will receive follow-up at the outpatient clinic as per their needs.

Interventions

Other: - Dignio Digital Remote Care intervention group

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.

Other: - Usual Care Control group

Participants in the control group will receive follow-up at the outpatient clinic as per their needs.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Oslo University Hospital, Oslo, Norway

Status

Recruiting

Address

Oslo University Hospital

Oslo, ,

Site Contact

Heidi Holmen, PhD

heidho@ous-hf.no

004723070000

University Hospital of North Norway, Tromsø, Norway

Status

Enrolling by invitation

Address

University Hospital of North Norway

Tromsø, ,