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Communication Model to Self-Care - Regardless of Health Literacy

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
Sponsored by
University College of Northern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Disease focused on measuring Health literacy, Nursing, Self-Care, Primary Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg Municipality

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
June 3, 2021
Last Updated
May 19, 2022
Sponsor
University College of Northern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT04929314
Brief Title
Communication Model to Self-Care - Regardless of Health Literacy
Official Title
A Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College of Northern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Health literacy, Nursing, Self-Care, Primary Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Non-Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
Other Intervention Name(s)
Communication Model to Self-Care - Regardless of Health Literacy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health-related quality of Life (Measured with the standardised European Quality of Life 5 Dimensions (EQ5D-3L) health-related quality of life questionnaire)
Description
Health status
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Healthcare costs
Description
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)
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa KE Hæsum, Ph.D
Organizational Affiliation
University College of Northern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Municipality
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

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Communication Model to Self-Care - Regardless of Health Literacy

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