NCT03216603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

3.2 years

First QC Date

July 7, 2017

Last Update Submit

December 13, 2021

Conditions

Keywords

Health literacy

Outcome Measures

Primary Outcomes (1)

  • Change of admissions

    Number of re-admissions

    Eight weeks, six months and one year

Secondary Outcomes (7)

  • Change of health literacy

    Eight weeks, six months and one year

  • Change of disease specific quality of life

    Eight weeks, six months and one year

  • Change of e-Health

    Eight weeks, six months and one year

  • Change of physical function

    Eight weeks, six months and one year

  • Change of self-management

    Eight weeks, six months and one year

  • +2 more secondary outcomes

Study Arms (2)

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.

Behavioral: Health literacy intervention group

Usual care group

NO INTERVENTION

Usual care group will receive usual follow up

Interventions

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).

Health literacy intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lovisenberg Diakonale Hospital

Oslo, 0440, Norway

Location

Related Publications (2)

  • 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.

  • Borge 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christine Borge, Phd

    University of Oslo and Lovisenberg Diaconal Hospital

    PRINCIPAL INVESTIGATOR
  • Astrid K. Wahl, Phd

    University of Oslo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 13, 2017

Study Start

November 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations