Medication Adherence[sPATH]NCT02823795
The Supporting Patient Activation in Transition to Home Intervention
A study testing Motivational Interviewing in people with Medication Adherence and Self-care, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Self-care, Heart Failure
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesSweden
- Study dates
- Sep 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Akutkliniken, Karolinska University Hospital
Huddinge
Karolinska Universitetssjukhuset, Lung- Allergikliniken
Huddinge
About this study
Official title: The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
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.
- Being tested
- Motivational Interviewing
- Keywords
- Patient participation, Empowerment, Medication management, Symptom management, Self determination theory, Motivational Interviewing
- Medical subject headings
- Medication Adherence, Heart Failure, Pulmonary Disease, Chronic Obstructive, Patient Participation, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| sPATH | Experimental | Motivational Interviewing in five sessions post hospital discharge Receives: Behavioral: Motivational Interviewing |
| Control | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-hospitalization
Registry data from the Swedish Register for Health Care Encounters
Measured: 90 days
Secondary outcomes (6)
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
Measured: 30, 90 and 180 days
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
Measured: 30, 90 and 180 days
Patient activation
Patient reported data using the Patient Activation Measure, 13 item
Measured: 30, 90 and 180 days
Health related quality of life
Patient reported data using the EQ-5D-5L
Measured: 30, 90 and 180 days
Basic Psychological Needs
Patient reported data using the the Basic Psychological Need Satisfaction \& Frustration Scale, 18 items
Measured: 30, 90 and 180 days
Depression
Patient reported data using PHQ-9 (Patient Health Questionnaire)
Measured: 30, 90 and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startSep 2016
- Primary completion30 Jun 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Vårdalstiftelsen, Forte
- Responsible party
- Principal investigator, Mirjam Ekstedt, Karolinska Institutet
- Investigators
- Mirjam Ekstedt, Professor, Principal investigator, LIME, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823795
- Sponsor's protocol ID
- C751231003
- Other IDs
- Dnr 2014-0026, Dnr 2014-4948
- Acronym
- [sPATH]
- Status last verified
- Sep 2020
- First submitted
- 1 Jul 2016
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40228854Adelsjo 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.
PubMed 38987669Brandberg 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 34330857Flink 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 30683140Flink 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02823795
- Acronym / sponsor ID
- [sPATH] / C751231003
- Keywords
- Patient participation, Empowerment, Medication management, Symptom management, Self determination theory, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Vårdalstiftelsen, Forte
- Study start
- Sep 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sPATH | Experimental | Behavioral: Motivational InterviewingMotivational Interviewing in five sessions post hospital discharge |
| Control | No intervention | –Care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingPatients 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). | Behavioural | sPATH |
Primary outcome
Re-hospitalization
Time frame: 90 days
Registry data from the Swedish Register for Health Care Encounters
6 secondary outcomes
Healthcare usage
Time frame: 30, 90 and 180 days
Medication adherence
Time frame: 30, 90 and 180 days
Patient activation
Time frame: 30, 90 and 180 days
Health related quality of life
Time frame: 30, 90 and 180 days
Basic Psychological Needs
Time frame: 30, 90 and 180 days
Depression
Time frame: 30, 90 and 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Derived from this study: PubMed 40228854Kaltenbrunner 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.
- Derived from this study: PubMed 38987669Adelsjo 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.
- Derived from this study: PubMed 34330857Brandberg 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.
- Derived from this study: PubMed 30683140Flink 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.
- Derived from this study: PubMed 28698319Flink 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Ekstedt, Professor principal investigator
LIME, Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Medication Adherence and Self-care, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-hospitalization (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02823795, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.