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Digital Outpatient Services

Digital Outpatient Services - a Controlled Multicenter Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05068869
Enrollment
180
Registered
2021-10-06
Start date
2021-09-12
Completion date
2024-12-31
Last updated
2023-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Cancer, Interstitial Lung Disease, Long Term Pain

Keywords

Digital outpatient services, Health literacy, mHealth, eHealth, Satisfaction, Controlled trial

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.

Interventions

OTHERDignio 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.

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

Sponsors

University Hospital of North Norway
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Health literacyBaseline, 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)

Secondary

MeasureTime frameDescription
Change in Satisfaction with digital services3 months, and 6 months follow-up.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)
Change in Digital health literacyBaseline, 3 months, and 6 months months follow-up.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)
Change in Health/ quality of lifeBaseline, 3 months, and 6 months follow-up.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.
Change in Perceived safety in a pandemicBaseline, 3 months, and 6 months follow-up.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 .

Other

MeasureTime frameDescription
Experiences with digital outpatient servicesAfter 6 moths of study follow-up, the investigators will conduct the interviewsQualitative interviews with patients and healthcare personnel will be conducted to assess their experiences with the new services.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026