Improving the continuity of care in schizophrenia through an intervention delivered via mobile phones and internet: a pilot study

ISRCTN ISRCTN15399617
DOI https://doi.org/10.1186/ISRCTN15399617
Secondary identifying numbers N/A
Submission date
03/07/2015
Registration date
12/07/2015
Last edited
18/08/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Schizophrenia is a severe mental illness with a high risk of relapse. Following discharge from inpatient or day hospital psychiatric treatment, patients are confronted with the challenges of daily life and the management of their illness. Continuous support is important during this period, yet challenging to implement as part of routine mental healthcare. The aftercare intervention HEINS is delivered via mobile phones and internet and provides continuous low-threshold support to patients following their discharge from inpatient or day hospital treatment. In case of symptoms becoming worse, more intense professional support is offered to participants. It is expected that participation in the aftercare intervention has positive effects on patients’ well-being and on their utilization of mental healthcare services following their discharge from the hospital. Overall, the study’s findings should help to improve the continuity of care for patients with schizophrenia.

Who can participate?
Adult patients discharged from treatment for schizophrenia, schizotypal, or delusional disorder at the Department of General Psychiatry, University Hospital Heidelberg, Germany. Participation in the study requires that patients undergo treatment as usual following their discharge from the hospital (i.e., they have to have an outpatient mental healthcare provider). Furthermore, participation requires that patients have access to the Internet, possess a mobile phone, and have sufficient knowledge of the German language.

What does the study involve?
Participants are randomly assigned to one of two groups, i.e. either they receive treatment as usual or they receive treatment as usual plus participation in the aftercare intervention HEINS which is delivered via Internet and mobile phone for six months. HEINS is made up of several modules, i.e., psychoeducation, an individualized crises plan, and counselling via chat and/or telephone. The central module is a monitoring and feedback system. Once a week, participants answer a short questionnaire on their adherence to medication, sleep, anxiety, social contacts, and well-being via their mobile phone. Participants receive an automated feedback message referring to their current status and changes. In case of severe impairment participants are contacted by the hospital in order to evaluate the situation and provide further support if necessary.

What are the possible benefits and risks of participating?
The intervention aims at strengthening self-management competencies, and the detection of early warning signs in order to prevent relapses and counteract deteriorations as early as possible. There are no known risks associated with participation.

Where is the study run from?
Center for Psychotherapy Research and the Department of General Psychiatry at the University Hospital Heidelberg (Germany).

When is the study starting and how long is it expected to run for?
July 2015 to April 2016

Who is funding the study?
Center for Psychotherapy Research, University Hospital Heidelberg (Germany)

Who is the main contact?
Dr Stephanie Bauer
stephanie.bauer@med.uni-heidelberg.de

Contact information

Dr Stephanie Bauer
Scientific

Center for Psychotherapy Research
University Hospital Heidelberg
Bergheimer Str. 54
Heidelberg
69115
Germany

Phone 00496221567345
Email stephanie.bauer@med.uni-heidelberg.de

Study information

Study designProspective single center randomized controlled trial; Pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleIs an aftercare intervention delivered via mobile phones and internet a feasible add-on to treatment as usual for patients with schizophrenia?
Study acronymHEINS
Study objectives1. The intervention HEINS is well-accepted by the target population
2. The assessments and procedures prove to be feasible
3. Participation in HEINS yields to improved well-being six months after discharge from inpatient treatment compared to TAU
4. Participation in HEINS yields to improved service utilization in case of crisis within six months after discharge from inpatient treatment compared to TAU
Ethics approval(s)Ethikkommission der Medizinischen Fakultät Heidelberg [Ethics Committee of the Faculty of Medicine, University of Heidelberg], 01/06/2015, ref: S-147/2015
Health condition(s) or problem(s) studiedSchizophrenia, schizotypal, and delusional disorders; ICD-10 Categories F20-F29
InterventionAll patients undergo treatment at the Department of General Psychiatry at the University Hospital Heidelberg. Prior to discharge patients are randomized to one of two arms:
1. TAU (Treatment as usual): Patients in the TAU condition undergo the standard outpatient follow-up treatment, provided by an outpatient psychiatrist or the outpatient unit of the Department of General Psychiatry.
2. TAU plus HEINS (“Heidelberger Nachsorgeprogramm fuer Schizophrenie / Heidelberg aftercare program for schizophrenia”): HEINS is an aftercare program based on mobile phone and Internet technology. The intervention comprises several modules, i.e., psychoeducation, an individualized crises plan, and counselling via chat and/or telephone. The central module is a monitoring and feedback system. Once a week, participants answer a short questionnaire on their adherence to medication, sleep, anxiety, social contacts, and well-being via their mobile phone. Participants receive an automated feedback message referring to their current status and changes. In case of severe impairment participants are contacted by the hospital in order to evaluate the situation and provide further support if necessary. The duration of participation in HEINS is six months.
Intervention typeBehavioural
Primary outcome measure1. Willingness to participate: The proportion of the target population willing to participate in the study
2. Adherence: Utilization of HEINS modules and rate of drop-out from the intervention
3. Attitudes, expectations, and satisfaction: Attitudes and expectations towards Internet-based interventions at the beginning of participation and satisfaction with HEINS at the end of participation
Secondary outcome measures1. Feasibility of assessment instruments (questionnaires and interviews)
2. Feasibility of procedures and external randomization
3. Intervention effects on well-being six months after discharge from hospital (measured with the Positive and Negative Syndrome Scale; PANSS)
4. Intervention effects on service utilization within six months after discharge from hospital (measured with the Longitudinal Follow-up Evaluation; LIFE)
Overall study start date01/01/2015
Completion date31/12/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteria1. ICD-10 Diagnosis Categories F20-F29 (Schizophrenia, schizotypal and delusional disorders)
2. Inpatient or day hospital treatment at the University Hospital Heidelberg, Department of General Psychiatry
3. Outpatient follow-up treatment provided by an outpatient provider or the outpatient unit of the Department of General Psychiatry
4. Age: at least 18 years old
5. Sufficient German language skills
6. Mobile phone
7. Access to the Internet
8. Capability to give informed consent
Key exclusion criteria1. Dependence syndrome (except tacacco) in the last 2 years
2. Severe craniocerebral injury
3. Acute psychotic disorder with a duration of less than 4 weeks
Date of first enrolment15/07/2015
Date of final enrolment15/04/2016

Locations

Countries of recruitment

  • Germany

Study participating centre

Department of General Psychiatry
University Hospital Heidelberg
Voßstr. 2
Heidelberg
69115
Germany

Sponsor information

University Hospital Heidelberg Center for Psychotherapy Research
University/education

Bergheimer Str. 54
Heidelberg
69115
Germany

Website www.psyres.de
ROR logo "ROR" https://ror.org/013czdx64

Funders

Funder type

Not defined

Center for Psychotherapy Research, University Hospital Heidelberg (Germany)

No information available

Results and Publications

Intention to publish date31/12/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planTo be confirmed at a later date
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 25/11/2021 18/08/2023 Yes No

Editorial Notes

18/08/2023: Publication reference added.
08/01/2020: Internal review.