Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease

Renal Insufficiency, Chronic Clinical Trial

— TICCKD  

Official title:

Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04854382
• Other study ID #: REK 144084/2020
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 215
• Est. completion date: December 31, 2023
• Est. primary completion date: March 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• Kidney Diseases
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Tailored information
Tailored information about coronavirus for patients with chronic kidney disease by information videos followed by a teach back procedure

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog	Akershus

Sponsors (1)

Lead Sponsor	Collaborator
Ivar Anders Eide

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 months
Secondary	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.	9 months
Secondary	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	9 months
Secondary	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	9 months