- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04929314
Communication Model to Self-Care - Regardless of Health Literacy
A Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Aalborg, Denmark, 9000
- Aalborg Municipality
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention
Participants in the intervention group receive specialised nursing care that focuses on the interactive communication model.
The nurses who deliver care to participants in the intervention group receive specific education and training in order to be able to provide nursing based on the interactive communication model and more individualised nursing based on health literacy level.
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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.
Other Names:
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No Intervention: Control
The participants in the control group receive usual care.
The 98 municipalities in Denmark have a specialised role in community care and rehabilitation where nursing and practical help is carried out in the patients' own homes.
Community care is usually provided at regular intervals based on a clinical evaluation of the patients' needs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health-related quality of Life (Measured with the standardised European Quality of Life 5 Dimensions (EQ5D-3L) health-related quality of life questionnaire)
Time Frame: 6 months
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Health status
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Healthcare costs
Time Frame: 6 months
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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)
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Lisa KE Hæsum, Ph.D, University College of Northern Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-000992-45
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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