Condition category
Not Applicable
Date applied
07/06/2017
Date assigned
04/08/2017
Last edited
04/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr jose ignacio Emparanza

ORCID ID

Contact details

Paseo Begiristain 115-117
San Sebastián
20014
Spain
+34 (0)943 007 147
joseignacio.emparanza@osakidetza.eus

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EAP2016

Study information

Scientific title

Self-control strategies in chronic diseases (at home chronic and dependent patients): a randomized controlled trial

Acronym

Study hypothesis

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

Gipuzkoa ethics review board, 24/05/2016, ref: 05/2016

Study design

Cluster randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2017

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Frail patients
2. Living at home
3. Barthel Index score lower than 60
4. Agree to participate
5. No age limits

Participant type

Patient

Age group

All

Gender

Both

Target number of participants

60

Participant exclusion criteria

Do not agree to participate

Recruitment start date

01/02/2017

Recruitment end date

31/03/2018

Locations

Countries of recruitment

Spain

Trial participating centre

OSI Donostialdea. Hospital Universitario Donostia
Paseo Begiristain 115-117
San Sebastián
20014
Spain

Sponsor information

Organisation

Hospital Universitario Donostia

Sponsor details

Paseo Begiristain 115-117
San Sebastián
20014
Spain
+34 (0)943 007 147
joseignacio.emparanza@osakidetza.eus

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

CIBER Centro de Investigación Biomédica en Red

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Jose Artetxe (josemaria.artecheocasar@osakidetza.eus).

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes