The Supporting Patient Activation in Transition to Home Intervention

Not Applicable

Completed

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

• Registration Number: NCT02823795
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-06
• Study Start: 2016-09
• Primary Completion: 2018-06-30
• Study Completion: 2018-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-20
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Re-hospitalization	90 days	Registry data from the Swedish Register for Health Care Encounters

Secondary Outcome Measures

Name	Time	Method
Healthcare usage	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
Health related quality of life	30, 90 and 180 days	Patient reported data using the EQ-5D-5L
Medication adherence	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
Patient activation	30, 90 and 180 days	Patient reported data using the Patient Activation Measure, 13 item
Depression	30, 90 and 180 days	Patient reported data using PHQ-9 (Patient Health Questionnaire)
Basic Psychological Needs	30, 90 and 180 days	Patient reported data using the the Basic Psychological Need Satisfaction \& Frustration Scale, 18 items

Trial Locations

Locations (2)

Akutkliniken, Karolinska University Hospital; 🇸🇪 Huddinge, Sweden

Karolinska Universitetssjukhuset, Lung- Allergikliniken; 🇸🇪 Huddinge, Sweden