Comparing different strategies for chronic patients self-control in dependent patients living at home

ISRCTN	ISRCTN68655887
DOI	https://doi.org/10.1186/ISRCTN68655887
Secondary identifying numbers	EAP2016

Submission date: 07/06/2017
Registration date: 04/08/2017
Last edited: 04/08/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Since 2005 a set of interventions aimed at patients with chronic (long-term) diseases were introduced in order to reduce the re-admission rate and improve quality of life. The aim of this study is to assess whether these questionnaire-based interventions are also effective in home-based frail patients at detecting exacerbation (worsening) of chronic conditions.

Who can participate?
Frail patients who are living at home

What does the study involve?
Participating Primary Health-Care Centers are randomly allocated to either the experimental group or the control group. Within the experimental group, participants are randomly allocated to phone follow-up or follow-up using the mobile phone application. Participants in the phone group call the case nurse every 2 weeks or any time the patient has any alarm signs or symptoms. Participants in the app group answer a short questionnaire every morning and the app compares the situation with the previous one to see if the patient has worsened or stayed the same, then suggests either a change in treatment (sent to the doctor to confirm it) or to stay with the previous treatment. Mortality (death rate), emergency department visits, consultations, phone calls, number of visits, quality of life and quality of care are compared between the two groups.

What are the possible benefits and risks of participating?
Participants may benefit from better care and better perceived quality of life. No risks are anticipated because this is not a treatment intervention, it is a different way of providing care to these patients.

Where is the study run from?
Hospital Universitario Donostia (Spain)

When is the study starting and how long is it expected to run for?
January 2017 to March 2018

Who is funding the study?
CIBER Centro de Investigación Biomédica en Red (Spain)

Who is the main contact?
Dr Jose Ignacio Emparanza
joseignacio.emparanza@osakidetza.eus

Contact information

Dr jose ignacio Emparanza
Scientific

Paseo Begiristain 115-117
San Sebastián
20014
Spain

Phone	+34 (0)943 007 147
Email	joseignacio.emparanza@osakidetza.eus

Study information

Study design	Cluster randomized trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Self-control strategies in chronic diseases (at home chronic and dependent patients): a randomized controlled trial
Study objectives	The use of an app (web based) or a mobile phone can diminish the need for physical consultation and visits to the emergency department, improving perceived quality of care as compared with the conventional care in chronic patients.
Ethics approval(s)	Gipuzkoa ethics review board, 24/05/2016, ref: 05/2016
Health condition(s) or problem(s) studied	Chronic diseases in frail patients (at-home dependent patients)
Intervention	Five Primary Health-Care Centers (PHCs) from the OSI Donostialdea are randomised to the experimental group and five PHCs to the control group. Within the experimental group (five PHCs), individuals will be randomized to telephone follow-up or follow-up using the mobile phone application. The control group receive usual care. Phone group: Phone call every 2 weeks from the patient to the case nurse or any time the patient has any of the alarm signs or symptoms established App group: The patient answers a short questionnaire every morning. The app compares the situation with the previous one to see if the patient has worsened or remains at the basal situation. Then suggest an action: change in treatment (send to the doctor to confirm it) or stick to the previous treatment Mortality, emergency department visits and physical consultations in relation to the chronic process, telephone calls, number of visits and quality of life (EuroQol) and the quality of care are collected via questionnaire. The total intervention duration is 1 year, the same as the follow-up.
Intervention type	Other
Primary outcome measure	1. Number of physical consultations, taken from information systems during the 1-year follow up 2. Number of visits to ED, taken from information systems during the 1-year follow up 3. Mortality, taken from mortality registry at the end of the 1-year follow-up
Secondary outcome measures	1. Number of admissions, registered by information systems during the 1-year follow up 2. Length of stay, the mean number of days if the patients suffers more than one admission, registered by information systems during the 1-year follow up 3. Perceived quality of care, measured using standard questionnaire at the end of the 1-year follow-up
Overall study start date	01/01/2017
Completion date	31/03/2018

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Both
Target number of participants	60
Key inclusion criteria	1. Frail patients 2. Living at home 3. Barthel Index score lower than 60 4. Agree to participate 5. No age limits
Key exclusion criteria	Do not agree to participate
Date of first enrolment	01/02/2017
Date of final enrolment	31/03/2018

Locations

Countries of recruitment

Spain

Study participating centre

OSI Donostialdea. Hospital Universitario Donostia

Paseo Begiristain 115-117
San Sebastián
20014
Spain

Sponsor information

Hospital Universitario Donostia
Hospital/treatment centre

Paseo Begiristain 115-117
San Sebastián
20014
Spain

Phone	+34 (0)943 007 147
Email	joseignacio.emparanza@osakidetza.eus
"ROR"	https://ror.org/04fkwzm96

Funders

Funder type

Research organisation

CIBER Centro de Investigación Biomédica en Red

No information available

Results and Publications

Intention to publish date	31/12/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Jose Artetxe (josemaria.artecheocasar@osakidetza.eus).