Condition category
Mental and Behavioural Disorders
Date applied
04/08/2014
Date assigned
15/09/2014
Last edited
15/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Psychomatic disorders involve both the mind and the body. Some physical diseases are thought to be particularly affected by mental factors such as stress and anxiety. With increasing age comes the increasing risk of developing multiple health conditions, mental disorders and a number of social challenges (such as isolation, loss of independence, boredom or feeling inadequate) . Here, we want to assess the success of a short patient orientated treatment for elderly patients with complex health care needs. Using an interview method called INTERMED (IM-E), suitable participants will be identified from those that have taken part in ESTHER - a large study about multimorbidity (existence of two or more long-term health conditions) and frailty in old age.

Who can participate?
Elderly people aged 60 years and older with complex health care needs . Participants are recruited from the ESTHER study.

What does the study involve?
Patients are randomly allocated into one of two groups. Those in group 1 (the control group) are visited at their home and given some general written information about available psychological or social support facilities. Feedback from the visit can be given to their GP. Those in group 2 (experimental group) are given the same information in an initial home visit. However, they are then also visited by a trained psychosomatic doctor. Depending on the results from the IM-E, tailored information is provided on diagnosed chronic diseases, a (potential) mental disorder, psychological or social support facilities, and possible coordination of care. Supportive counselling regarding being able to manage and cope with chronic conditions are given and appointments with specialists scheduled as needed. Feedback is provided to the GP. Those in the experimental group receive follow-up phone calls one month and then 3 months after the initial visit. All participants (in both groups) take part in a short telephone interview after 6 months.

What are the possible benefits and risks of participating?
All participants will be assessed closely by a professional team at the beginning of the study. Participants of both groups may benefit from the written general information. There are no risks of physical injury or harm.

Where is the study run from?
Department of General Internal Medicine and Psychosomatics, University Hospital Heidelberg (Germany)

When is the study starting and how long is it expected to run for?
July 2011 to November 2014

Who is funding the study?
German Ministry of Research and Education (BMBF) (Germany)

Who is the main contact?
Dr Beate Wild
Beate.Wild@med.uni-heidelberg.de

Trial website

http://esther.dkfz.org/esther/esther-net.html

Contact information

Type

Scientific

Primary contact

Dr Beate Wild

ORCID ID

Contact details

University Hospital Heidelberg
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
+49 (0) 6221 56 8663
beate.wild@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

German Ministry of Research and Education (BMBF) 01ET1004B

Study information

Scientific title

Short intervention targeting psychosomatic care in elderly patients with complex health care needs – a randomized controlled trial

Acronym

ASSIST

Study hypothesis

The aim of the study is to assess the efficacy of a short patient-oriented intervention targeting psychosomatic care in elderly patients with complex health care needs. The primary hypothesis of the randomized controlled trial (RCT) is that compared to the control group, the intervention group shows a better outcome regarding health-related quality of life (HRQOL) at the six-month follow-up.

Ethics approval

1. Ethics Committee of Saarland, 30/05/2011, ref. Ha67/00
2. Ethics Committee of the University of Heidelberg, 12/05/2011, ref. Nr. S-126/2011

Study design

Randomized controlled two-armed trial, ratio of intervention to control-group of 1:1

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Patients with complex bio-psycho-social health care needs (according to the INTERMED for the
Elderly interview)

Intervention

In the control condition, general written information is provided at the conclusion of a regular home visit (e.g. about psychological or social support facilities, compliance, mental disorders). In addition, feedback of the home visit can be provided to the general practitioner of the patient (GP).

In the experimental condition, general written information is provided at the conclusion of a regular home visit. In addition, in a second home visit is conducted by a trained psychosomatic doctor. Depending on the outcome in the different domains of the IM-E, information will be given about diagnosed chronic diseases, a (potential) mental disorder, psychological or social support facilities, and possible coordination of care. Supportive counselling regarding self-management and coping with chronic conditions can be given. The family can be involved in the counselling meeting. Appointments with specialists can be scheduled if necessary. Feedback can be provided to the GP. In the first and third month after the intervention home visit, follow-up phone calls with the participants will be done to remind them of the consultation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Health-related quality of life (HRQOL) measured by the SF-12, six months after randomization

Secondary outcome measures

1. Depressive symptom severity measured by the PHQ, six months after randomization
2. Somatic symptom severity measured by the PHQ, six months after randomization
3. Hospitalization rate, six months after randomization

Overall trial start date

10/07/2011

Overall trial end date

01/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants of the 11-year follow-up of the ESTHER study
2. IM-E interview score ≥ 17
3. Written informed consent

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

224

Participant exclusion criteria

1. Severe cognitive disturbances
2. Psychotic disorder
3. Terminal illness

Recruitment start date

10/07/2011

Recruitment end date

01/11/2014

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Heidelberg
Heidelberg
69120
Germany

Sponsor information

Organisation

German Ministry of Research and Education (BMBF) (Germany)

Sponsor details

Heinemannstr. 2
Bonn
53175
Germany
+49 (0) 228 9957 0
bmbf@bmbf.bund.de

Sponsor type

Government

Website

http://www.bmbf.de/

Funders

Funder type

Government

Funder name

German Ministry of Research and Education (BMBF) 01ET1004B (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes