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Digital Outpatient Services

Primary Purpose

Epilepsy, Cancer, Interstitial Lung Disease

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Dignio Digital Remote Care intervention group
Usual Care Control group
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Epilepsy focused on measuring Digital outpatient services, Health literacy, mHealth, eHealth, Satisfaction, Controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital
  • University Hospital of North Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Dignio Digital Remote Care intervention group

Usual Care Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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.
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" .
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)

Full Information

First Posted
September 19, 2021
Last Updated
February 15, 2023
Sponsor
Oslo University Hospital
Collaborators
University Hospital of North Norway
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1. Study Identification

Unique Protocol Identification Number
NCT05068869
Brief Title
Digital Outpatient Services
Official Title
Digital Outpatient Services - a Controlled Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
University Hospital of North Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Cancer, Interstitial Lung Disease, Long Term Pain
Keywords
Digital outpatient services, Health literacy, mHealth, eHealth, Satisfaction, Controlled trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dignio Digital Remote Care intervention group
Arm Type
Other
Arm Description
Participants will receive the MyDignio app for individualized follow-up for 6 months.
Arm Title
Usual Care Control group
Arm Type
Other
Arm Description
Participants in the control group will receive follow-up at the outpatient clinic as per their needs.
Intervention Type
Other
Intervention Name(s)
Dignio Digital Remote Care intervention group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care Control group
Intervention Description
Participants in the control group will receive follow-up at the outpatient clinic as per their needs.
Primary Outcome Measure Information:
Title
Change in Health literacy
Description
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)
Time Frame
Baseline, 3 months, and 6 months follow-up.
Secondary Outcome Measure Information:
Title
Change in Digital health literacy
Description
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)
Time Frame
Baseline, 3 months, and 6 months months follow-up.
Title
Change in Health/ quality of life
Description
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.
Time Frame
Baseline, 3 months, and 6 months follow-up.
Title
Change in Perceived safety in a pandemic
Description
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" .
Time Frame
Baseline, 3 months, and 6 months follow-up.
Title
Change in Satisfaction with digital services
Description
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)
Time Frame
3 months, and 6 months follow-up.
Other Pre-specified Outcome Measures:
Title
Experiences with digital outpatient services
Description
Qualitative interviews with patients and healthcare personnel will be conducted to assess their experiences with the new services.
Time Frame
After 6 moths of study follow-up, the investigators will conduct the interviews

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Fosse, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Heidi Holmen
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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