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Health Literacy in People With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Health literacy intervention group
Sponsored by
Lovisenberg Diakonale Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Health literacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Lovisenberg Diakonale Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health literacy intervention group

Usual care group

Arm Description

Health 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 will receive usual follow up

Outcomes

Primary Outcome Measures

Change of admissions
Number of re-admissions

Secondary Outcome Measures

Change of health literacy
Questionnaire
Change of disease specific quality of life
Questionnaire
Change of e-Health
Questionnaire
Change of physical function
Questionnaire
Change of self-management
Questionnaire
Change of psychological stress
Questionnaire
Change of self-efficacy
Questionnaire

Full Information

First Posted
July 7, 2017
Last Updated
December 13, 2021
Sponsor
Lovisenberg Diakonale Hospital
Collaborators
University of Oslo, Norwegian Extra Foundation for Health and Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT03216603
Brief Title
Health Literacy in People With Chronic Obstructive Pulmonary Disease
Official Title
Health Literacy. An Intervention on Organized Information and Health Care for People With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lovisenberg Diakonale Hospital
Collaborators
University of Oslo, Norwegian Extra Foundation for Health and Rehabilitation

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Health literacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health literacy intervention group
Arm Type
Experimental
Arm Description
Health literacy intervention group will receive self-management help using a motivating interviewing technique delivered by nurses trained on motivating interviewing technique and COPD.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Usual care group will receive usual follow up
Intervention Type
Behavioral
Intervention Name(s)
Health literacy intervention group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change of admissions
Description
Number of re-admissions
Time Frame
Eight weeks, six months and one year
Secondary Outcome Measure Information:
Title
Change of health literacy
Description
Questionnaire
Time Frame
Eight weeks, six months and one year
Title
Change of disease specific quality of life
Description
Questionnaire
Time Frame
Eight weeks, six months and one year
Title
Change of e-Health
Description
Questionnaire
Time Frame
Eight weeks, six months and one year
Title
Change of physical function
Description
Questionnaire
Time Frame
Eight weeks, six months and one year
Title
Change of self-management
Description
Questionnaire
Time Frame
Eight weeks, six months and one year
Title
Change of psychological stress
Description
Questionnaire
Time Frame
Eight weeks, six months and one year
Title
Change of self-efficacy
Description
Questionnaire
Time Frame
Eight weeks, six months and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Borge, Phd
Organizational Affiliation
University of Oslo and Lovisenberg Diaconal Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Astrid K. Wahl, Phd
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
Lovisenberg Diakonale Hospital
City
Oslo
ZIP/Postal Code
0440
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Health Literacy in People With Chronic Obstructive Pulmonary Disease

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