Health Literacy in People With Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Health literacy intervention group

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0440
    • Lovisenberg Diakonale Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of admissions	Number of re-admissions	Eight weeks, six months and one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of health literacy	Questionnaire	Eight weeks, six months and one year
Change of disease specific quality of life	Questionnaire	Eight weeks, six months and one year
Change of e-Health	Questionnaire	Eight weeks, six months and one year
Change of physical function	Questionnaire	Eight weeks, six months and one year
Change of self-management	Questionnaire	Eight weeks, six months and one year
Change of psychological stress	Questionnaire	Eight weeks, six months and one year
Change of self-efficacy	Questionnaire	Eight weeks, six months and one year

Collaborators and Investigators

• Sponsor: Lovisenberg Diakonale Hospital
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Health literacy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No