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The Supporting Patient Activation in Transition to Home Intervention ([sPATH])

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02823795
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : September 23, 2020
Sponsor:
Collaborators:
Vårdalstiftelsen
Forte
Information provided by (Responsible Party):
Mirjam Ekstedt, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Medication Adherence Self-care Heart Failure Chronic Obstructive Pulmonary Disease Behavioral: Motivational Interviewing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial
Actual Study Start Date : September 2016
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : September 2018

Arm Intervention/treatment
Experimental: sPATH
Motivational Interviewing in five sessions post hospital discharge
Behavioral: Motivational 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).

No Intervention: Control
Care as usual



Primary Outcome Measures :
  1. Re-hospitalization [ Time Frame: 90 days ]
    Registry data from the Swedish Register for Health Care Encounters


Secondary Outcome Measures :
  1. Healthcare usage [ Time Frame: 30, 90 and 180 days ]
    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

  2. Medication adherence [ Time Frame: 30, 90 and 180 days ]
    Patient reported data using the Morisky Medication Adherence Scale, 8 items, and registry data using medicine data from the Swedish Prescribed Drug Registry

  3. Patient activation [ Time Frame: 30, 90 and 180 days ]
    Patient reported data using the Patient Activation Measure, 13 item

  4. Health related quality of life [ Time Frame: 30, 90 and 180 days ]
    Patient reported data using the EQ-5D-5L

  5. Basic Psychological Needs [ Time Frame: 30, 90 and 180 days ]
    Patient reported data using the the Basic Psychological Need Satisfaction & Frustration Scale, 18 items

  6. Depression [ Time Frame: 30, 90 and 180 days ]
    Patient reported data using PHQ-9 (Patient Health Questionnaire)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823795


Locations
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Sweden
Akutkliniken, Karolinska University Hospital
Huddinge, Sweden
Karolinska Universitetssjukhuset, Lung- Allergikliniken
Huddinge, Sweden
Sponsors and Collaborators
Karolinska Institutet
Vårdalstiftelsen
Forte
Investigators
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Principal Investigator: Mirjam Ekstedt, Professor LIME, Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mirjam Ekstedt, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02823795    
Other Study ID Numbers: C751231003
Dnr 2014-0026 ( Other Grant/Funding Number: Vårdalsstiftelsen )
Dnr 2014-4948 ( Other Grant/Funding Number: Forte )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mirjam Ekstedt, Karolinska Institutet:
Patient participation
Empowerment
Medication management
Symptom management
Self determination theory
Motivational Interviewing
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases