Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease (TICCKD)
Primary Purpose
Renal Insufficiency, Chronic
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tailored information
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Insufficiency, Chronic focused on measuring Digital health literacy, Health literacy, Fear of coronavirus, Self-perceived health, Teach-back
Eligibility Criteria
Inclusion Criteria:
- Chronic kidney disease stage 5
Exclusion Criteria:
- Covid-19 during last 12 months. Dementia or other reason why cannot participate like major depression, psychosis or hospitalized persons with severe frailty.
Sites / Locations
- Akershus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Tailored information about coronavirus using information videos followed by a teach-back procedure
Controls have access to information videos, but do not receive the teach-back procedure (the intervention)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04854382
Brief Title
Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease
Acronym
TICCKD
Official Title
Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ivar Anders Eide
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
Keywords
Digital health literacy, Health literacy, Fear of coronavirus, Self-perceived health, Teach-back
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
215 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Tailored information about coronavirus using information videos followed by a teach-back procedure
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Controls have access to information videos, but do not receive the teach-back procedure (the intervention)
Intervention Type
Behavioral
Intervention Name(s)
Tailored information
Intervention Description
Tailored information about coronavirus for patients with chronic kidney disease by information videos followed by a teach back procedure
Primary Outcome Measure Information:
Title
Digital health literacy
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Health literacy
Description
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.
Time Frame
9 months
Title
Self-perceived Health
Description
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
Time Frame
9 months
Title
Anxiety / concern
Description
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
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic kidney disease stage 5
Exclusion Criteria:
Covid-19 during last 12 months. Dementia or other reason why cannot participate like major depression, psychosis or hospitalized persons with severe frailty.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivar A Eide, PhD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease
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