Renal Insufficiency, ChronicTICCKDNCT04854382
Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease
A study testing Tailored information in people with Renal Insufficiency, Chronic, run by Ivar Anders Eide at 1 site in Norway.
Trial summary
Randomized clinical trial focusing on the effect of tailored information on Covid-19 for patients with chronic kidney disease stage 5 on health literacy, anxiety and self-perceived health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Tailored information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteNorway
- Study dates
- 14 Apr 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic kidney disease stage 5
Who cannot join
- Covid-19 during last 12 months. Dementia or other reason why cannot participate like major depression, psychosis or hospitalized persons with severe frailty.
Trial locations and contacts
1 site in 1 country.
About this study
Randomized clinical trial focusing on the effect of tailored information on Covid-19 for patients with chronic kidney disease stage 5 on health literacy, anxiety and self-perceived health.
Read the detailed description
This single-center randomized open clinical trial in persons with chronic kidney disease stage 5 investigates the effect of information about coronavirus targeted at the study population, using study specific information videos followed by a teach-back method. We measure digital, functional, interactive and critical health literacy, fear of coronavirus and self-perceived health at baseline and end-of-study. Patients are followed from May-July 2021 through February 2022 (study period 7-9 months).
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Tailored information
- Keywords
- Digital health literacy, Health literacy, Fear of coronavirus, Self-perceived health, Teach-back
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored informationBehavioural
Tailored information about coronavirus for patients with chronic kidney disease by information videos followed by a teach back procedure
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Tailored information about coronavirus using information videos followed by a teach-back procedure Receives: Behavioral: Tailored information |
| Control group | No intervention | Controls have access to information videos, but do not receive the teach-back procedure (the intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital health literacy
Digital health literacy measured by Electronic Health Literacy Scale (shortened eHEALS, Norman et al 2006), a questionnaire composed of 8 items measuring combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems, Likert scale 1 (lowest, worst digital health literacy) - 5 (highest, best digital health literacy), with max score 40.
Measured: 9 months
Secondary outcomes (3)
Health literacy
Health literacy measured by Health Literacy Questionnaire (shortened HLQ, Osborne et al 2013), a questionnaire composed of 44 items (9 dimensions) measuring reading and writing skills (functional), interactive and critical literacy. Likert scale 1 (lowest, worst health literacy) - 4 (highest, best health literacy) for some items and 1 (lowest, similar) - 5 (highest) for other items with calculations of mean score for each of the 9 dimensions.
Measured: 9 months
Self-perceived Health
Self-perceived health measured with the EQ-5D-5L (EuroQol Group 1990), a questionnaire composed of 5 items / dimensions (mobility, autonomy, daily activities, pain, and anxiety and depression), Likert scale 1 (lowest / best health) - 5 (highest / worst health) with max score 25
Measured: 9 months
Anxiety / concern
Anxiety / concern measured by the questionnaire Fear of corona scale (Ahorsu et al 2020), Likert scale 1 (lowest, least concern) - 5 (highest, most concern) with max score 35
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start14 Apr 2021
- Primary completion10 Mar 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ivar Anders Eide
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ivar Anders Eide, University Hospital, Akershus
- Investigators
- Ivar A Eide, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854382
- Sponsor's protocol ID
- REK 144084/2020
- Acronym
- TICCKD
- Status last verified
- Mar 2022
- First submitted
- 13 Apr 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04854382
- Acronym / sponsor ID
- TICCKD / REK 144084/2020
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Digital health literacy, Health literacy, Fear of coronavirus, Self-perceived health, Teach-back
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Ivar Anders EideUniversity, hospital or other
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical trial focusing on the effect of tailored information on Covid-19 for patients with chronic kidney disease stage 5 on health literacy, anxiety and self-perceived health.
Detailed description
This single-center randomized open clinical trial in persons with chronic kidney disease stage 5 investigates the effect of information about coronavirus targeted at the study population, using study specific information videos followed by a teach-back method. We measure digital, functional, interactive and critical health literacy, fear of coronavirus and self-perceived health at baseline and end-of-study. Patients are followed from May-July 2021 through February 2022 (study period 7-9 months).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Tailored informationTailored information about coronavirus using information videos followed by a teach-back procedure |
| Control group | No intervention | –Controls have access to information videos, but do not receive the teach-back procedure (the intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic kidney disease stage 5
Key exclusion criteria (1 listed)
- Covid-19 during last 12 months. Dementia or other reason why cannot participate like major depression, psychosis or hospitalized persons with severe frailty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored informationTailored information about coronavirus for patients with chronic kidney disease by information videos followed by a teach back procedure | Behavioural | Intervention group |
Primary outcome
Digital health literacy
Time frame: 9 months
Digital health literacy measured by Electronic Health Literacy Scale (shortened eHEALS, Norman et al 2006), a questionnaire composed of 8 items measuring combined knowledge, comfort, and perceived skills at finding, evaluating, and applying electronic health information to health problems, Likert scale 1 (lowest, worst digital health literacy) - 5 (highest, best digital health literacy), with max score 40.
3 secondary outcomes
Health literacy
Time frame: 9 months
Self-perceived Health
Time frame: 9 months
Anxiety / concern
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivar A Eide, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored information in people with Renal Insufficiency, Chronic, run by Ivar Anders Eide at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital health literacy (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.