The Supporting Patient Activation in Transition to Home Intervention

Heart Failure Clinical Trial

— [sPATH]  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823795
• Other study ID #: C751231003
• Secondary ID: Dnr 2014-0026Dnr
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Sweden	Akutkliniken, Karolinska University Hospital	Huddinge
Sweden	Karolinska Universitetssjukhuset, Lung- Allergikliniken	Huddinge

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Forte, Vårdalstiftelsen

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-hospitalization	Registry data from the Swedish Register for Health Care Encounters	90 days
Secondary	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	30, 90 and 180 days
Secondary	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	30, 90 and 180 days
Secondary	Patient activation	Patient reported data using the Patient Activation Measure, 13 item	30, 90 and 180 days
Secondary	Health related quality of life	Patient reported data using the EQ-5D-5L	30, 90 and 180 days
Secondary	Basic Psychological Needs	Patient reported data using the the Basic Psychological Need Satisfaction & Frustration Scale, 18 items	30, 90 and 180 days
Secondary	Depression	Patient reported data using PHQ-9 (Patient Health Questionnaire)	30, 90 and 180 days