Communication Model to Self-Care - Regardless of Health Literacy

Sponsor
University College of Northern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT04929314
Collaborator
(none)
48
1
2
13
3.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
The trial is single-blinded, as the participants are unaware of their group allocation. The community nurses will not be blinded, as they will know whether they perform the intervention or not.
Primary Purpose:
Prevention
Official Title:
A Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
May 1, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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.
Other Names:
  • Communication Model to Self-Care - Regardless of Health Literacy
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Health-related quality of Life (Measured with the standardised European Quality of Life 5 Dimensions (EQ5D-3L) health-related quality of life questionnaire) [6 months]

      Health status

    Secondary Outcome Measures

    1. Healthcare costs [6 months]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aalborg Municipality Aalborg Denmark 9000

    Sponsors and Collaborators

    • University College of Northern Denmark

    Investigators

    • Principal Investigator: Lisa KE Hæsum, Ph.D, University College of Northern Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University College of Northern Denmark
    ClinicalTrials.gov Identifier:
    NCT04929314
    Other Study ID Numbers:
    • 2020-000992-45
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    May 20, 2022
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University College of Northern Denmark
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 20, 2022