Chronic Obstructive Pulmonary DiseaseNCT03216603
Health Literacy in People With Chronic Obstructive Pulmonary Disease
A study testing Health literacy intervention group in people with Chronic Obstructive Pulmonary Disease, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
Trial summary
Health literacy refers to personal and relational factors affecting a person's ability to acquire, understand and use information about health and health services. In a need assessment study it was found that, the health services need to focus on health literacy factors in the follow up of patients with chronic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Health literacy intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- 1 Nov 2017to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD,
- Above 18 years,
- Admitted to a medical department at the main intervention hospital, l
- Live in the sites belonging to the intervention hospital.
Who cannot join
- Not diagnosed with COPD,
- Not above 18 years,
- Not admitted to a medical department at the main intervention hospital, and
- Not living in the sites belonging to the intervention hospital.
- Cognitive failure
- Patients that are investigated or treated for cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Literacy. An Intervention on Organized Information and Health Care for People With Chronic Obstructive Pulmonary Disease (COPD)
Health literacy refers to personal and relational factors affecting a person's ability to acquire, understand and use information about health and health services. In a need assessment study it was found that, the health services need to focus on health literacy factors in the follow up of patients with chronic obstructive pulmonary disease (COPD).
Thus, this project evaluate the effect a of a health literacy partnership health promotion intervention (hospital, municipalities, university) after discharge from hospital with the use of motivational interviewing and tailored follow-ups on re-admission, health literacy, self-management quality of life and cost in people with COPD compared with usual care.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Health literacy intervention group
- Keywords
- Health literacy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health literacy intervention groupBehavioural
In the health literacy intervention group all patients will receive self-management help using a motivating interviewing (MI) technique delivered by two MI and COPD trained nurses once a week for eight weeks after hospitalization. Subsequently, the contact between the patients and the nurses will be by follow up motivational telephone calls once a month or more if needed for four months (i.a a total of six months intervention period).
| Study group | Role | What they receive |
|---|---|---|
| Health literacy intervention group | Experimental | Health literacy intervention group will receive self-management help using a motivating interviewing technique delivered by nurses trained on motivating interviewing technique and COPD. Receives: Behavioral: Health literacy intervention group |
| Usual care group | No intervention | Usual care group will receive usual follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of admissions
Number of re-admissions
Measured: Eight weeks, six months and one year
Secondary outcomes (7)
Change of health literacy
Questionnaire
Measured: Eight weeks, six months and one year
Change of disease specific quality of life
Questionnaire
Measured: Eight weeks, six months and one year
Change of e-Health
Questionnaire
Measured: Eight weeks, six months and one year
Change of physical function
Questionnaire
Measured: Eight weeks, six months and one year
Change of self-management
Questionnaire
Measured: Eight weeks, six months and one year
Change of psychological stress
Questionnaire
Measured: Eight weeks, six months and one year
Change of self-efficacy
Questionnaire
Measured: Eight weeks, six months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian Extra Foundation for Health and Rehabilitation
- Responsible party
- Principal investigator, Christine Råheim Borge, Lovisenberg Diakonale Hospital
- Investigators
- Christine Borge, Phd, Principal investigator, University of Oslo and Lovisenberg Diaconal HospitalAstrid K. Wahl, Phd, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216603
- Sponsor's protocol ID
- 298
- Status last verified
- Dec 2021
- First submitted
- 7 Jul 2017
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larsen MH, Wahl AK, Borge CR. Patients' and healthcare personnel's experiences of a health-literacy intervention in chronic obstructive pulmonary disease - a qualitative study. BMC Health Serv Res. 2025 Sep 30;25(1):1256. doi: 10.1186/s12913-025-13299-z.
PubMed 41029694Borge CR, Larsen MH, Osborne RH, Aas E, Kolle IT, Reinertsen R, Lein MP, Thorn M, Lind RM, Groth M, Strand O, Andersen MH, Moum T, Engebretsen E, Wahl AK. Impacts of a health literacy-informed intervention in people with chronic obstructive pulmonary disease (COPD) on hospitalization, health literacy, self-management, quality of life, and health costs - A randomized controlled trial. Patient Educ Couns. 2024 Jun;123:108220. doi: 10.1016/j.pec.2024.108220. Epub 2024 Feb 16.
PubMed 38458089
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Literacy. An Intervention on Organized Information and Health Care for People With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03216603
- Acronym / sponsor ID
- 298
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Health literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Norwegian Extra Foundation for Health and Rehabilitation
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Jul 2017 (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.
Health literacy refers to personal and relational factors affecting a person's ability to acquire, understand and use information about health and health services. In a need assessment study it was found that, the health services need to focus on health literacy factors in the follow up of patients with chronic obstructive pulmonary disease (COPD).
Thus, this project evaluate the effect a of a health literacy partnership health promotion intervention (hospital, municipalities, university) after discharge from hospital with the use of motivational interviewing and tailored follow-ups on re-admission, health literacy, self-management quality of life and cost in people with COPD compared with usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health literacy intervention group | Experimental | Behavioral: Health literacy intervention groupHealth literacy intervention group will receive self-management help using a motivating interviewing technique delivered by nurses trained on motivating interviewing technique and COPD. |
| Usual care group | No intervention | –Usual care group will receive usual follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with COPD,
- Above 18 years,
- Admitted to a medical department at the main intervention hospital, l
- Live in the sites belonging to the intervention hospital.
Key exclusion criteria (6 listed)
- Not diagnosed with COPD,
- Not above 18 years,
- Not admitted to a medical department at the main intervention hospital, and
- Not living in the sites belonging to the intervention hospital.
- Cognitive failure
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 |
|---|---|---|
| Health literacy intervention groupIn the health literacy intervention group all patients will receive self-management help using a motivating interviewing (MI) technique delivered by two MI and COPD trained nurses once a week for eight weeks after hospitalization. Subsequently, the contact between the patients and the nurses will be by follow up motivational telephone calls once a month or more if needed for four months (i.a a total of six months intervention period). | Behavioural | Health literacy intervention group |
Primary outcome
Change of admissions
Time frame: Eight weeks, six months and one year
Number of re-admissions
7 secondary outcomes
Change of health literacy
Time frame: Eight weeks, six months and one year
Change of disease specific quality of life
Time frame: Eight weeks, six months and one year
Change of e-Health
Time frame: Eight weeks, six months and one year
Change of physical function
Time frame: Eight weeks, six months and one year
Change of self-management
Time frame: Eight weeks, six months and one year
Change of psychological stress
Time frame: Eight weeks, six months and one year
Change of self-efficacy
Time frame: Eight weeks, six months and one year
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 14 Dec 2021.
- Derived from this study: PubMed 41029694Larsen MH, Wahl AK, Borge CR. Patients' and healthcare personnel's experiences of a health-literacy intervention in chronic obstructive pulmonary disease - a qualitative study. BMC Health Serv Res. 2025 Sep 30;25(1):1256. doi: 10.1186/s12913-025-13299-z.
- Derived from this study: PubMed 38458089Borge CR, Larsen MH, Osborne RH, Aas E, Kolle IT, Reinertsen R, Lein MP, Thorn M, Lind RM, Groth M, Strand O, Andersen MH, Moum T, Engebretsen E, Wahl AK. Impacts of a health literacy-informed intervention in people with chronic obstructive pulmonary disease (COPD) on hospitalization, health literacy, self-management, quality of life, and health costs - A randomized controlled trial. Patient Educ Couns. 2024 Jun;123:108220. doi: 10.1016/j.pec.2024.108220. Epub 2024 Feb 16.
- Individual participant dataSharing planned: No
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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.
Christine Borge, Phd principal investigator
University of Oslo and Lovisenberg Diaconal Hospital
Astrid K. Wahl, Phd study chair
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health literacy intervention group in people with Chronic Obstructive Pulmonary Disease, run by Lovisenberg Diakonale Hospital at 1 site in Norway.
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 4 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 14 Dec 2021. 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 Norway. 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?
Change of admissions (time frame: Eight weeks, six months and one year). 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 NCT03216603, which also lists 2 linked publications.
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 14 Dec 2021.