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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04929314
Other study ID # 2020-000992-45
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date May 1, 2022

Study information

Verified date December 2020
Source University College of Northern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Healthcare systems all over the world are developing in a way that compels patients to become more active in the management of their own health and disease - a development that changes the role of modern patients and the skills needed to navigate the healthcare system. Demographic changes resulting in more elderly people have led to increases in the burden of chronic diseases and put pressure on increasingly scarce healthcare resources. One strategy for overcoming this burden is to reduce the utilization of healthcare resources in the secondary sector by reducing the length of stay and placing more health care services in the primary sector, thus allowing more rehabilitation actions, where the goal is to have patients take control of their own life situation and health. This means that community nurses are compelled to strengthen citizens' ability to manage their own disease and everyday life. A focus on health literacy and its significance for everyday life with chronic disease can increase the probability of citizens' acquiring the instructions and guidance given by community nurses, and thus strengthen the ability for self-care and self-rehabilitation. In line with this, a systematic interactive communication model has been developed to help strengthen self-care for citizens with chronic diseases. For more information, see the description of the intervention above. The study is targeted citizens, who receive community nursing. A possible benefit of participating is an improvement of quality of life in everyday life for citizens receiving community nursing. No risks related to participation in the study. The study is run from four community nursing districts in Aalborg Municipality. The development of the intervention was initiated in september 2019, and the study is expected finalised in july 2022. This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Ability to give informed consent - Age > 18 - Fixed residence in Aalborg Municipality - Receives home healthcare services for a period of more than three months - Ability to speak, read and write Danish Exclusion Criteria: - Diagnosed with a severe psychiatric disease - Diagnosed with dementia or other severe cognitive impairments - Terminal - Unable to understand and speak Danish - Pregnancy - Participation in other studies that could effect the primary outcome of this study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
The central element of the intervention is the interactive communication model. A website that contains easy-to-understand knowledge and material about various chronic diseases such as chronic obstructive pulmonary disease, diabetes, heart failure, as well as knowledge and material about wound care, compression treatment and prevention of infections has been developed. Information within each topic is given based on the interactive communication model. The idea is that community nurses should not themselves assess what characterizes an easy-to-understand level or the amount of information for each individual citizen, which seeks to ensure a systematic and uniformity in the work with self-care and more self-sufficient citizens. At the same time, the model makes it possible to take into account the individual citizen's knowledge and competencies (level of HL). Further, the nurses receive specialised education regarding HL to complement their use of the interactive communication model.

Locations

Country Name City State
Denmark Aalborg Municipality Aalborg

Sponsors (1)

Lead Sponsor Collaborator
University College of Northern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health-related quality of Life (Measured with the standardised European Quality of Life 5 Dimensions (EQ5D-3L) health-related quality of life questionnaire) Health status 6 months
Secondary Healthcare costs Consumption of healthcare services in both primary and secondary sector (e.g. in- and outpatient costs, medication costs, costs from visiting general practitioners, and community care costs) 6 months
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