Communication Model to Self-Care - Regardless of Health Literacy

NCT ID: NCT04929314

Last Updated: 2022-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Communication Model to Self-Care - Regardless of Health Literacy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University College of Northern Denmark

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa KE Hæsum, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University College of Northern Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aalborg Municipality

Aalborg, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

Haesum LKE, Hejlesen OK, Udsen FW. An Interactive Communication Model for Self-Care-Regardless of Health Literacy: Protocol for a Quasi-Experimental Study. JMIR Res Protoc. 2023 Mar 31;12:e37673. doi: 10.2196/37673.

Reference Type DERIVED
PMID: 37000515 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-000992-45

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.