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Trial record 1 of 1 for:    NCT 05068869
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Digital Outpatient Services

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ClinicalTrials.gov Identifier: NCT05068869
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
University Hospital of North Norway
Information provided by (Responsible Party):
Heidi Holmen, Oslo University Hospital

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.


Condition or disease Intervention/treatment Phase
Epilepsy Cancer Interstitial Lung Disease Postoperative Pain Long Term Pain Other: Dignio Digital Remote Care intervention group Other: Usual Care Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Digital Outpatient Services - a Controlled Multicenter Study
Actual Study Start Date : September 12, 2021
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
Dignio Digital Remote Care intervention group
Participants will receive the MyDignio app for individualized follow-up for 12 months.
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.


Usual Care Control group
Participants in the control group will receive follow-up at the outpatient clinic as per their needs.
Other: Usual Care Control group
Participants in the control group will receive follow-up at the outpatient clinic as per their needs.




Primary Outcome Measures :
  1. Change in Health literacy [ Time Frame: Baseline, 3 months, 6 months and 12 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 Outcome Measures :
  1. Change in Digital health literacy [ Time Frame: Baseline, 3 months, 6 months and 12 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)


  2. Change in Health/ quality of life [ Time Frame: Baseline, 3 months, 6 months and 12 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.

  3. Change in Perceived safety in a pandemic [ Time Frame: Baseline, 3 months, 6 months and 12 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" .

  4. Change in Satisfaction with digital services [ Time Frame: 3 months, 6 months and 12 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)



Other Outcome Measures:
  1. Experiences with digital outpatient services [ Time Frame: After 6 moths of study follow-up, the investigators will conduct the interviews ]
    Qualitative interviews with patients and healthcare personnel will be conducted to assess their experiences with the new services.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • post-operative use of opioids

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05068869


Contacts
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Contact: Heidi Holmen, PhD 004723070000 heidho@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Heidi Holmen, PhD         
University Hospital of North Norway Enrolling by invitation
Tromsø, Norway
Sponsors and Collaborators
Oslo University Hospital
University Hospital of North Norway
Investigators
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Study Director: Erik Fosse, PhD Oslo University Hospital
Principal Investigator: Heidi Holmen Oslo University Hospital
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Responsible Party: Heidi Holmen, Post doctor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT05068869    
Other Study ID Numbers: 21/06826
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heidi Holmen, Oslo University Hospital:
Digital outpatient services
Health literacy
mHealth
eHealth
Satisfaction
Controlled trial
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases