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Completed

NCT Number: NCT02823795

The Supporting Patient Activation in Transition to Home Intervention

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

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).

Primary outcomes

  1. Re-hospitalization

    Time frame: 90 days

    Registry data from the Swedish Register for Health Care Encounters

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Forte
  • Vårdalstiftelsen

Registry information

Official study title

The Supporting Patient Activation in Transition to Home (sPATH) Intervention - a Study Protocol of Randomized Controlled Trial

Acronym: [sPATH]

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2016
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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