NCT02823795

Brief Summary

This study evaluates if motivational interviewing sessions aiming to motivate recently discharged patients with either chronic obstructive pulmonary disease or congestive heart failure to be active in post-discharge self-management can reduce re-hospitalization rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

July 1, 2016

Last Update Submit

September 20, 2020

Conditions

Medication AdherenceSelf-careHeart FailureChronic Obstructive Pulmonary Disease

Keywords

Patient participationEmpowermentMedication managementSymptom managementSelf determination theoryMotivational Interviewing

Outcome Measures

Primary Outcomes (1)

  • Re-hospitalization

    Registry data from the Swedish Register for Health Care Encounters

    90 days

Secondary Outcomes (6)

  • Healthcare usage

    30, 90 and 180 days

  • Medication adherence

    30, 90 and 180 days

  • Patient activation

    30, 90 and 180 days

  • Health related quality of life

    30, 90 and 180 days

  • Basic Psychological Needs

    30, 90 and 180 days

  • +1 more secondary outcomes

Study Arms (2)

sPATH

EXPERIMENTAL

Motivational Interviewing in five sessions post hospital discharge

Behavioral: Motivational Interviewing

Control

NO INTERVENTION

Care as usual

Interventions

Motivational InterviewingBEHAVIORAL

Patients will get motivational interviewing sessions by a patient activation coach (medical social workers and/or nurses trained in motivational interviewing and in the intervention) in five post hospital discharge sessions (whereof one face-to-face, four by phone) aiming to increase patient motivation to become active in self-management (medication management, care plan/follow-up, symptoms/signs of worsening condition, contacts with health care provider).

sPATH

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 years or older with chronic obstructive pulmonary disease or congestive heart failure admitted at a short-term medical ward and who are living in their private home.

You may not qualify if:

  • Diagnoses of dementia or cognitive impairment, and need of interpreter to participate in conversations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Akutkliniken, Karolinska University Hospital

Huddinge, Sweden

Location

Karolinska Universitetssjukhuset, Lung- Allergikliniken

Huddinge, Sweden

Location

Related Publications (5)

  • Kaltenbrunner M, Flink M, Brandberg C, Hellstrom A, Ekstedt M. Motivational interviewing for reducing rehospitalisation and improving patient activation among patients with heart failure or chronic obstructive pulmonary disease: a randomised controlled trial. BMJ Open. 2025 Apr 14;15(4):e081931. doi: 10.1136/bmjopen-2023-081931.

    PMID: 40228854DERIVED

  • Adelsjo I, Lehnbom EC, Hellstrom A, Nilsson L, Flink M, Ekstedt M. The impact of discharge letter content on unplanned hospital readmissions within 30 and 90 days in older adults with chronic illness - a mixed methods study. BMC Geriatr. 2024 Jul 10;24(1):591. doi: 10.1186/s12877-024-05172-1.

    PMID: 38987669DERIVED

  • Brandberg C, Ekstedt M, Flink M. Self-management challenges following hospital discharge for patients with multimorbidity: a longitudinal qualitative study of a motivational interviewing intervention. BMJ Open. 2021 Jul 30;11(7):e046896. doi: 10.1136/bmjopen-2020-046896.

    PMID: 34330857DERIVED

  • Flink M, Brandberg C, Ekstedt M. Why patients decline participation in an intervention to reduce re-hospitalization through patient activation: whom are we missing? Trials. 2019 Jan 25;20(1):82. doi: 10.1186/s13063-019-3187-9.

    PMID: 30683140DERIVED

  • Flink M, Lindblad M, Frykholm O, Kneck A, Nilsen P, Arestedt K, Ekstedt M. The Supporting Patient Activation in Transition to Home (sPATH) intervention: a study protocol of a randomised controlled trial using motivational interviewing to decrease re-hospitalisation for patients with COPD or heart failure. BMJ Open. 2017 Jul 10;7(7):e014178. doi: 10.1136/bmjopen-2016-014178.

    PMID: 28698319DERIVED

MeSH Terms

Conditions

Medication AdherenceHeart FailurePulmonary Disease, Chronic ObstructivePatient ParticipationEmpowerment

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHeart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSocial Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Mirjam Ekstedt, Professor

    LIME, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

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
Professor

Study Record Dates

First Submitted

July 1, 2016

First Posted

July 6, 2016

Study Start

September 1, 2016

Primary Completion

June 30, 2018

Study Completion

September 1, 2018

Last Updated

September 23, 2020

Record last verified: 2020-09

Locations

SE(2)