Condition category
Circulatory System
Date applied
02/07/2015
Date assigned
25/08/2015
Last edited
25/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Stroke is the second leading cause of death and the first cause of long-term neurological disability worldwide. Several rehabilitation programs have been proven to be effective but patients often feel unprepared to deal with long-term problems, especially at the end of the rehabilitation program. Therapeutic Patient Education (TPE) aims to improve awareness and self-management of the consequences of the disease. We currently do not know the best way to integrate TPE interventions into the rehabilitation process. In this study we aim to design and standardize a structured TPE intervention for stroke patients in a very early phase after stroke, and specifically in a rehabilitation hospital setting. We will also evaluate the impact of the intervention on patient empowerment, care continuity, quality of life and social reintegration. The third aim is to analyze the feasibility of such an intervention in terms of costs, workload, acceptability and satisfaction of patients and caregivers.

Who can participate?
First stroke patients with mild/moderate to severe disability.

What does the study involve?
Patients admitted to Rehabilitation Unit 1 (Bologna) and will receive the usual care for stroke. Patients admitted to Rehabilitation Unit 2 Reggio E.-AO and Rehabilitation Unit 3 Modena-AUSL will receive the TPE intervention. All participants will complete questionnaires and will be assessed at hospital admission, at discharge and 1 month after discharge.

What are the possible benefits and risks of participating?
The benefits associated with taking part in our study are: improvements in self-management of disability, psychological well-being, caregiver burden, physical functioning and ambulatory function. No significant risks are expected for participants. Participants can consult a psychologist if needed.

Where is the study run from?
The study will run from three Physical Medicine and Rehabilitation Units in Italy:
1. Physical Medicine and Rehabilitation Unit of St. Orsola Malpighi Hospital, Bologna
2. Physical Medicine and Rehabilitation Unit of IRCCS Santa Maria Nuova, Reggio Emilia
3. Rehabilitation Medicine Unit of St. Agostino–Estense Baggiovara New Hospital, Modena

When is the study starting and how long is it expected to run for?
The study started in June 2014 and will run for 24 months.

Who is funding the study?
The Regional Agency for Health and Social Care, Regione Emilia Romagna, in the framework of Region-University Program - Area 2 ‘Clinical Governance’ 2013.

Who is the main contact?
Mariangela Taricco, MD
mariangela.taricco@aosp.bo.it

Trial website

Contact information

Type

Public

Primary contact

Dr Mariangela Taricco

ORCID ID

http://orcid.org/0000-0002-4028-1877

Contact details

Via Albertoni
15
Bolgna
40138
Italy
+39 (0)51 2142286
mariangela.taricco@aosp.bo.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Patient Therapeutic Education (PTE) in the rehabilitation process of stroke patients: improving self management and fostering transition from hospital to community. A non-randomized clinical trial

Acronym

Study hypothesis

The Therapeutic Patient Education (TPE) will be more effective than treatment as usual (TAU) in first stroke patients with mild/moderate to severe disability assessed at hospital admission, at discharge and 1 months after discharge.

Ethics approval

Ethics Committee of the Hospital Trust St. Orsola Malpighi of Bologna, of the Hospital Trust Santa Maria Nuova of Reggio Emilia and of the Hospital Trust St. Agostino–Estense Baggiovara, 11/02/2014, CODE Ec: LAY/2013

Study design

Non-randomized clinical trial with concurrent controls

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

First stroke patients with mild/moderate to severe disability

Intervention

The project will be run in two phases:

Phase 1:
1. Design and standardization of the therapeutic education intervention; the intervention will be based on the Chronic Disease Self Management Program which will be adapted and tailored to the specific needs of stroke patients in the early rehabilitation phase.
2. Training of Program leaders, who will be health workers of the Rehabilitation Units involved in the Project as well as lay-leaders.
Both the design of the Program and the Training will be realized by a group of health care professionals of the Rehabilitation Units coordinated by a T-group Trainer of the Chronic Disease Self Management Program, assisted by a psychologist.
The intervention will consist of both individual interactions between patients and health care professionals, and group sessions, led by trained health care professionals and lay leaders.

Phase 2:
1. A non-randomized controlled study will be performed in three Rehabilitation Units in the Emilia Romagna Region; the Units are selected on the basis of similarities of the stroke rehabilitation pathway adopted. Patients admitted to Rehabilitation Unit 1 (Bologna) will receive 'usual care'; patients admitted to Rehabilitation Unit 2 Reggio E.-AO and Rehabilitation Unit 3 Modena-AUSL will receive the experimental intervention.
2. A feasibility assessment study will be conducted with special emphasis on the training costs, educational intervention costs, organizational impact, workload, satisfaction of both users and health care professionals.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Self-efficacy that will be measured using the Stroke Self-efficacy Questionnaire. Change of the scale scores at the end of treatment and at follow-up will be compared between the experimental group and the control group

Secondary outcome measures

1. SF-12, measuring health-related quality of life
2. Modified Barthel Index, measuring the ability to perform daily living activities
3. Geriatric Depression Scale, measuring the presence and severity of depression
4. Caregiver Strain Index, measuring the caregiver’s burden
5. Patients/caregiver satisfaction, measured using a self-report visual analog scale
6. Short Physical Performance Battery, measuring mobility
Changes of the scale scores at the end of treatment and at follow-up will be compared between the experimental group and the control group

Overall trial start date

15/06/2014

Overall trial end date

14/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who suffered a first stroke at the admission to hospital rehabilitation phase (age >18)
2. Having a caregiver as reference person
3. Mild/moderate to severe disability (modified Barthel Index <70/100)
4. Communication disability from absent to mild (Communication Disability Scale <3)
5. Informed consent form signed both by patient and caregiver

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240 stroke survivors, 120 for each intervention

Participant exclusion criteria

1. Previous stroke episodes
2. Severe cognitive impairment (MMSE<15/30, Communication Disability Scale > or=3)
3. Life threatening diseases
4. No consent to participation

Recruitment start date

01/10/2014

Recruitment end date

14/06/2015

Locations

Countries of recruitment

Italy

Trial participating centre

Physical Medicine and Rehabilitation Unit of St. Orsola Malpighi Hospital
Bologna
-
Italy

Trial participating centre

Physical Medicine and Rehabilitation Unit of IRCCS Santa Maria Nuova
Reggio Emilia
-
Italy

Trial participating centre

Rehabilitation Medicine Unit of St. Agostino–Estense Baggiovara New Hospital
Modena
-
Italy

Sponsor information

Organisation

Regional Agency for Health and Social Care, Regione Emilia-Romagna

Sponsor details

Viale Aldo Moro 21
Bolgna
40127
Italy

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Regional Agency for Health and Social Care, Regione Emilia Romagna, in the framework of Region-University Program - Area 2 'Clinical Governance' 2013

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of this study, comparing therapeutic patient education and treatment as usual in patients with stroke, will be disseminated via peer-reviewed publications and conference presentations.

Intention to publish date

01/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes