NCT05068869

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

September 19, 2021

Last Update Submit

November 30, 2023

Conditions

EpilepsyCancerInterstitial Lung DiseaseLong Term Pain

Keywords

Digital outpatient servicesHealth literacymHealtheHealthSatisfactionControlled trial

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline, 3 months, and 6 months follow-up.

Secondary Outcomes (4)

  • Change in Digital health literacy

    Baseline, 3 months, and 6 months months follow-up.

  • Change in Health/ quality of life

    Baseline, 3 months, and 6 months follow-up.

  • Change in Perceived safety in a pandemic

    Baseline, 3 months, and 6 months follow-up.

  • Change in Satisfaction with digital services

    3 months, and 6 months follow-up.

Other Outcomes (1)

  • Experiences with digital outpatient services

    After 6 moths of study follow-up, the investigators will conduct the interviews

Study Arms (2)

Dignio Digital Remote Care intervention group

OTHER

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

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.

Other: Usual Care Control group

Interventions

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.

Dignio Digital Remote Care intervention group
Usual Care Control groupOTHER

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

Usual Care Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo University Hospital

Oslo, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

Related Publications (3)

  • 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.

    PMID: 41538795DERIVED

  • Holmen 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.

    PMID: 40294411DERIVED

  • Holmen 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.

    PMID: 37428533DERIVED

MeSH Terms

Conditions

EpilepsyNeoplasmsLung Diseases, InterstitialPersonal Satisfaction

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Erik Fosse, PhD

    Oslo University Hospital

    STUDY DIRECTOR

  • Heidi Holmen

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doctor

Study Record Dates

First Submitted

September 19, 2021

First Posted

October 6, 2021

Study Start

September 12, 2021

Primary Completion

July 1, 2023

Study Completion

December 31, 2024

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)