Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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Tailored Information About the Coronavirus for Patients With Chronic Kidney Disease

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Behavioral: Tailored information


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Tailored information about coronavirus using information videos followed by a teach-back procedure | Behavioral: Tailored information<br>* Tailored information about coronavirus for patients with chronic kidney disease by information videos followed by a teach back procedure<br>|
| No Intervention: Control group<br>Controls have access to information videos, but do not receive the teach-back procedure (the intervention) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital health literacy, Health literacy, Fear of coronavirus, Self-perceived health, Teach-back