Health Literacy in People With Chronic Obstructive Pulmonary Disease

Sponsor

Lovisenberg Diakonale Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03216603

Collaborator

University of Oslo (Other), Norwegian Extra Foundation for Health and Rehabilitation (Other)

130

Enrollment

Location

Arms

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Behavioral: Health literacy intervention group	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Health Literacy. An Intervention on Organized Information and Health Care for People With Chronic Obstructive Pulmonary Disease (COPD)

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Health literacy intervention group Health literacy intervention group will receive self-management help using a motivating interviewing technique delivered by nurses trained on motivating interviewing technique and COPD.	Behavioral: Health literacy intervention group 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).
No Intervention: Usual care group Usual care group will receive usual follow up

Arm

Intervention/Treatment

Experimental: Health literacy intervention group

Health literacy intervention group will receive self-management help using a motivating interviewing technique delivered by nurses trained on motivating interviewing technique and COPD.

Behavioral: Health literacy intervention group

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).

No Intervention: Usual care group

Usual care group will receive usual follow up

Outcome Measures

Primary Outcome Measures

Change of admissions [Eight weeks, six months and one year]
Number of re-admissions

Secondary Outcome Measures

Change of health literacy [Eight weeks, six months and one year]
Questionnaire
Change of disease specific quality of life [Eight weeks, six months and one year]
Questionnaire
Change of e-Health [Eight weeks, six months and one year]
Questionnaire
Change of physical function [Eight weeks, six months and one year]
Questionnaire
Change of self-management [Eight weeks, six months and one year]
Questionnaire
Change of psychological stress [Eight weeks, six months and one year]
Questionnaire
Change of self-efficacy [Eight weeks, six months and one year]
Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lovisenberg Diakonale Hospital	Oslo		Norway	0440

Sponsors and Collaborators

Lovisenberg Diakonale Hospital
University of Oslo
Norwegian Extra Foundation for Health and Rehabilitation

Investigators

Principal Investigator: Christine Borge, Phd, University of Oslo and Lovisenberg Diaconal Hospital
Study Chair: Astrid K. Wahl, Phd, University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christine Råheim Borge, Researcher, Lovisenberg Diakonale Hospital

ClinicalTrials.gov Identifier:

NCT03216603

Other Study ID Numbers:

First Posted:

Jul 13, 2017

Last Update Posted:

Dec 14, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Christine Råheim Borge, Researcher, Lovisenberg Diakonale Hospital

Health literacy

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Dec 14, 2021