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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Tailored 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored information | Behavioral | Tailored information about coronavirus for patients with chronic kidney disease by information videos followed by a teach back procedure |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivar A Eide, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | Akershus | 1478 | Norway |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 8, 2025 | |
| Reset | Jun 26, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 1, 2020 | Apr 22, 2021 | Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2025 | Jun 26, 2025 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |