NCT04854382

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

April 13, 2021

Last Update Submit

March 13, 2022

Conditions

Renal Insufficiency, Chronic

Keywords

Digital health literacyHealth literacyFear of coronavirusSelf-perceived healthTeach-back

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Health literacy

    9 months

  • Self-perceived Health

    9 months

  • Anxiety / concern

    9 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Tailored information about coronavirus using information videos followed by a teach-back procedure

Behavioral: Tailored information

Control group

NO INTERVENTION

Controls have access to information videos, but do not receive the teach-back procedure (the intervention)

Interventions

Tailored informationBEHAVIORAL

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

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic kidney disease stage 5

You may not qualify if:

  • Covid-19 during last 12 months. Dementia or other reason why cannot participate like major depression, psychosis or hospitalized persons with severe frailty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ivar A Eide, PhD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant Doctor / Researcher

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 22, 2021

Study Start

April 14, 2021

Primary Completion

March 10, 2022

Study Completion

December 31, 2023

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)