Chronic DiseaseNCT04929314
Communication Model to Self-Care - Regardless of Health Literacy
A study testing Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level in people with Chronic Disease, run by University College of Northern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Chronic Disease
- Being tested
- Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
- Keywords
- Health literacy, Nursing, Self-Care, Primary Care
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy LevelBehavioural
Also called Communication Model to Self-Care - Regardless of Health Literacy
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Apr 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa KE Hæsum, Ph.D, Principal investigator, University College of Northern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929314
- Sponsor's protocol ID
- 2020-000992-45
- Status last verified
- Dec 2020
- First submitted
- 3 Jun 2021
- Last updated
- 20 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37000515
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level
- ClinicalTrials.gov ID
- NCT04929314
- Acronym / sponsor ID
- 2020-000992-45
- Conditions
- Chronic Disease
- Keywords
- Health literacy, Nursing, Self-Care, Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy LevelParticipants 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. |
| Control | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Diagnosed with a severe psychiatric disease
- Diagnosed with dementia or other severe cognitive impairments
- Terminal
- Unable to understand and speak Danish
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy LevelAlso: Communication Model to Self-Care - Regardless of Health LiteracyThe 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. | Behavioural | Intervention |
Primary outcome
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
Health status
1 secondary outcome
Healthcare costs
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 37000515Haesum 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa KE Hæsum, Ph.D principal investigator
University College of Northern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level in people with Chronic Disease, run by University College of Northern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04929314, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.