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CompletedNCT02823795[sPATH]Updated Sep 23, 2020

The Supporting Patient Activation in Transition to Home Intervention

An interventional study of Motivational Interviewing in Medication Adherence, Self-care and Heart Failure, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-23.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
118
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Included patients transition to home will be bridged through a telephone-call from a patient activation coach two days post-discharge. The patients will thereafter get motivational interviewing sessions by the same patient activation coach with the the goal that the patients are motivated to the knowledge, skills and confidence needed to manage the four main activity areas: 1) medication management; 2) adhere to care plan/ follow-up visits according to the discharge plan; 3) recognize indications (symptoms/signs) that the condition is worsening and how to respond; and 4) contact and manage relations/encounters with health care providers. Patients in control group will receive standard care, i.e. discharge and follow-up as in normal procedures. The investigators will use a randomization in permuted blocks of 10 intervention patients and 10 control patients included. To test the hypothesis that the re-hospitalizations rate is 15 % lower in the intervention group compared to the control group 242 patients (121 per group) are needed for power of 80% with the level of significance set to 5 % using two-sided chi-square.

02

Conditions studied

  • Medication Adherence
  • Self-care
  • Heart Failure
  • Chronic Obstructive Pulmonary Disease

Keywords

  • Patient participation
  • Empowerment
  • Medication management
  • Symptom management
  • Self determination theory
  • Motivational Interviewing
03

In context

Lung Diseases, Obstructive

2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 118 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

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

The exclusion criteria are related to the patients' possibilities to participate in the motivational interviewing sessions by phone.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
118 participants (actual)

Study arms

  • Experimental
    sPATH

    Motivational Interviewing in five sessions post hospital discharge

    Behavioral: Motivational Interviewing

  • No intervention
    Control

    Care as usual

Interventions

  • BehavioralMotivational Interviewing

    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).

06

What researchers measure

Primary outcomes

  1. Re-hospitalization

    Registry data from the Swedish Register for Health Care Encounters

    Time frame: 90 days

Secondary outcomes

  1. Healthcare usage

    Registry data from the Swedish Register for Health Care Encounters: re-hospitalization at 30 and 180 days. Emergency room and primary care visits at 30, 90 and 180 days

    Time frame: 30, 90 and 180 days

  2. Medication adherence

    Patient reported data using the Morisky Medication Adherence Scale, 8 items, and registry data using medicine data from the Swedish Prescribed Drug Registry

    Time frame: 30, 90 and 180 days

  3. Patient activation

    Patient reported data using the Patient Activation Measure, 13 item

    Time frame: 30, 90 and 180 days

  4. Health related quality of life

    Patient reported data using the EQ-5D-5L

    Time frame: 30, 90 and 180 days

  5. Basic Psychological Needs

    Patient reported data using the the Basic Psychological Need Satisfaction \& Frustration Scale, 18 items

    Time frame: 30, 90 and 180 days

  6. Depression

    Patient reported data using PHQ-9 (Patient Health Questionnaire)

    Time frame: 30, 90 and 180 days

07

Study locations

2 sites
  • Akutkliniken, Karolinska University Hospital
    Huddinge, Sweden
  • Karolinska Universitetssjukhuset, Lung- Allergikliniken
    Huddinge, Sweden
08

References and documents

Publications

  • 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. PubMed 34330857 ↗
  • 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. PubMed 30683140 ↗
  • 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. PubMed 28698319 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02823795
Lead sponsor
Karolinska Institutet
Collaborators
Vårdalstiftelsen, Forte
Responsible party
Mirjam Ekstedt (Professor, Karolinska Institutet) — Principal investigator
First posted
Jul 6, 2016
Start date
Sep 2016
Primary completion
Jun 30, 2018
Completion
Sep 2018
Last update
Sep 23, 2020

Study contacts

Mirjam Ekstedt, Professor
principal investigator · LIME, Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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