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The Supporting Patient Activation in Transition to Home Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02823795
Acronym
[sPATH]
Enrollment
118
Registered
2016-07-06
Start date
2016-09-30
Completion date
2018-09-30
Last updated
2020-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Patient participation, Empowerment, Medication management, Symptom management, Self determination theory, Motivational Interviewing

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.

Interventions

BEHAVIORALMotivational 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).

Sponsors

Vårdalstiftelsen
CollaboratorUNKNOWN
Forte
CollaboratorINDUSTRY
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Re-hospitalization90 daysRegistry data from the Swedish Register for Health Care Encounters

Secondary

MeasureTime frameDescription
Medication adherence30, 90 and 180 daysPatient reported data using the Morisky Medication Adherence Scale, 8 items, and registry data using medicine data from the Swedish Prescribed Drug Registry
Patient activation30, 90 and 180 daysPatient reported data using the Patient Activation Measure, 13 item
Healthcare usage30, 90 and 180 daysRegistry 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
Basic Psychological Needs30, 90 and 180 daysPatient reported data using the the Basic Psychological Need Satisfaction & Frustration Scale, 18 items
Depression30, 90 and 180 daysPatient reported data using PHQ-9 (Patient Health Questionnaire)
Health related quality of life30, 90 and 180 daysPatient reported data using the EQ-5D-5L

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026