Condition category
Signs and Symptoms
Date applied
18/05/2018
Date assigned
10/07/2018
Last edited
10/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Medically unexplained symptoms (MUS) are quite common in general practice. Referral to medical specialists does not reveal an organic cause and patients are referred back to their general practitioner. This results in frequent consultations without symptom reduction. These patients are costly not only because of direct medical costs, but also because of indirect costs resulting from sick leave and presenteeism. Existing approaches are not self-evident for migrant and low educated patients. Therefore, an alternative intervention has been developed in the Netherlands designed for female migrant patients who frequently visit their general practitioner and experience low levels of energy. The intervention aims to create opportunities to achieve positive experiences in different domains of life. Its purpose is to increase self-esteem and self-confidence which are necessary for empowerment, energy increase and quality of life. The aim of this study is to determine the cost-effectiveness of this new intervention as compared to care as usual.

Who can participate?
Female migrant patients, aged between 26 and 64, who had a contact with the participating general practices in this study

What does the study involve?
Participating general practices are randomly allocated to two groups, the intervention group and the control group. The intervention comprises a series of 13 group meetings including an introductory meeting, eight meetings that focus on specific themes, two visits to community centers or organizations, one concluding session and an evaluation meeting. The actual content of the group meetings is adapted to the specific group composition. The intervention takes place in groups because groups may contribute to the treatment goals: participants may stimulate and help each other, and it may help to increase their social network. Before the group meetings, an individual intake aims at defining the individual goals of each participating person. The intervention group meetings are guided by either a psychologist, a social worker or a socio-psychiatric nurse. Training for the intervention group has been provided shortly before the actual launch of the intervention by a coach, who was also involved in the development of the intervention. In the control group participants receive care as usual as provided by their GP. Patients’ quality of life and the costs (medical and non-medical) are measured 14 months later.

What are the possible benefits and risks of participating?
Possible benefits include better quality of life, higher energy level, higher self-esteem, more social contacts/support, less health complaints, and lower frequency of GP visits. No risks are expected.

Where is the study run from?
1. Erasmus School of Health Policy and Management (Netherlands)
2. Artsengroep Persoonsstraat (Netherlands)
3. M.C. Verbeek-Poot, huisarts (Netherlands)
4. Huisartspraktijk Jansen (Netherlands)
5. Gezondheidscentrum Nieuwe Westen (Netherlands)
6. Praktijk Mozaiek (Netherlands)
7. Gezondheidscentrum Tarwezigt (Netherlands)
8. Huisartspraktijk Nusteling (voorheen Harmsen en Lo Fo Wong) (Netherlands)
9. Huisartspraktijk Bijl (Netherlands)
10. Gezondheidscentrum Beverwaard (Netherlands)
11. Gezondheidscentrum Randweg (Netherlands)
12. Gezondheidscentrum Sint-Mariastraat (Netherlands)

When is the study starting and how long is it expected to run for?
January 2012 to July 2014

Who is funding the study?
ZonMw (Netherlands)

Who is the main contact?
Dr Anushka Choté
chote@eshpm.eur.nl

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anushka Choté

ORCID ID

Contact details

Burg. Oudlaan 50
Rotterdam
3062 PA
Netherlands
+31104088588
chote@eshpm.eur.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL40069.078.12

Study information

Scientific title

Energy in Balance: the cost effectiveness of an intervention aimed at migrant women with medically unexplained symptoms

Acronym

EiB

Study hypothesis

EIB intervention is more cost effective than care-as-usual.

Ethics approval

Medisch Ethische Toetsingscommissie Erasmus MC (Medical Ethics Board Erasmus MC), 11/12/2012, ref: MEC-2012-418

Study design

Cluster randomised controlled trial in general practice

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

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

Condition

Medically unexplained symptoms in general practice

Intervention

The study has been conducted in Rotterdam, the second largest city of the Netherlands. In Rotterdam 37,4% of the population has a non-western background. The study has been carried out in general practices willing to participate in the study and willing to give permission to make use of their patient information system for selection of patients. The study has been setup as a cluster randomized trial with two arms. Participating general practices were the clusters that were randomly allocated to two arms, the intervention group and the control group. Cluster randomization was chosen because the intervention was partly community oriented, which made it necessary that participants belonging to the same intervention group were living in the same neighborhood.

The intervention comprises a series of 13 group meetings including an introductory meeting, 8 meetings that focus on specific themes, two visits to community centers or organizations, one concluding session and an evaluation meeting. The actual content of the group meetings is adapted to the specific group composition. The intervention takes place in groups because groups may contribute to the treatment goals: participants may stimulate and help each other, and it may help to increase their social network. Prior to the group meetings, an individual intake aims at defining the individual goals of each participating person. The intervention group meetings are guided by either a psychologist, a social worker or a socio-psychiatric nurse. Training for the intervention group has been provided shortly before the actual launch of the intervention by a coach, who was also involved in the development of the intervention.

In the control condition participants received care as usual as provided by their GP

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Quality of life measured by SF-12 at baseline and follow-up (14 months later)
2. Costs (medical and non-medical) measured at baseline and follow-up

Secondary outcome measures

1. Depressive symptoms, assessed using the Patient Health Questionnaire-9 (PHQ-9). It assesses the presence of depressive symptoms in the past two weeks with four response options (‘not at all’, ‘several days’, ‘more than half the days’, ‘nearly every day’) and is often used in primary care settings The PHQ-9 score ranges from 0 to 27, because each of the 9 items can be scored from 0 (‘not at all’) to 3 (‘nearly every day’) . The PHQ-9 is part of the full PHQ for assessment of mental disorders.
2. Somatic symptoms, assessed using the Patient Health Questionnaire-15. The PHQ-15 is a validated instrument for detecting somatization disorders. The PHQ-15 comprises 15 somatic symptoms derived from the full PHQ. In this study 13 of the PHQ-15 somatic symptoms are included in the somatic symptom subscale. In this subscale patients are asked to rate the severity of each symptom as ‘not bothered at all’, ‘bothered a little’ or ‘bothered a lot’. Thus, in determining the score, each individual symptom is coded as 0, 1 or 2 and the total score ranges from 0 to 26. For Turkish speaking participants we made use of an existing Turkish translation of the PHQ.
2. Loneliness, measured using the De Jong Gierveld Loneliness Scale, a validated and reliable instrument for measurement of overall, emotional and social loneliness. The 6-item scale was used in which the patients are asked to what extent the statements apply to them. The scale consists of 6 statements on a 3-points scale (yes, more or less and no). Scale scores range from 0 to 6. Higher scores indicate higher loneliness.
3. Self-esteem, measured using the Rosenberg Self-Esteem Scale, a 10-item scale in which patients are asked to rate their agreement with 5 positively and 5 negatively worded self-statements on a 4-points scale ranging from ‘strongly agree’ to ‘strongly disagree’ The total score (that ranges from 0 to 30) is calculated such that higher scores reflect higher self-esteem.
Measured at face-to-face interviews at baseline (T0) and 14 months (T1) after inclusion

Overall trial start date

01/01/2012

Overall trial end date

01/07/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All female patients, aged between 26 and 64 years of age that had a contact with the general practice participating in this study in the year before a reference day, depending on the date a GP was included
2. Having at least 6 contacts in the year preceding the study
3. Having been diagnosed by the GP by means of preferable 4 or more ICPC codes below 30 in the last 60 or 12 months
This inclusion process was performed by the researchers, based on the information obtained from the Health Information System (HIS) of the participating practices.
4. Having a migrant background
Since the HIS does not include this information, this part of the inclusion process was carried out by the participating GPs

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

N=180; 20 clusters with 9 participants each

Participant exclusion criteria

1. Patients not able to communicate in Dutch
2. Patients in treatment at a mental health or social welfare service. Again, the HIS does not include this information, therefore this part of the selection process was carried out by the participating GPs
3. All those suffering at any point in time from:
3.1. Serous psychopathology
3.2. Multiple sclerosis, Parkinson’s disease and epilepsy
3.3. Down syndrome, HIV/Aids, blindness and liver cirrhosis
4. All those who suffered in the year in which they also had 6 contacts or more with their GP:
4.1. Acute alcohol abuse, drug and medication abuse, memory and concentration disorders
4.2. Unwanted pregnancy, abortus provocatus, delivery of a death child
4.3. Anorexia, boulimia
4.4. Problems as a consequence of violence
4.5. Any form of cancer
This part of the exclusion process again was performed by the researchers, based on the information obtained from the Health Information System of the participating practices.
5. Patients suffering from the following chronic diseases, because frequent consultations may be associated with such diseases:
5.1. Diabetes
5.2. Hypertension
5.3. Cardiovascular disease
5.4. Asthma
5.5. COPD
5.6. Anxiety
5.7. Depression

Recruitment start date

15/01/2013

Recruitment end date

27/07/2013

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus School of Health Policy and Management
Burg. Oudlaan 50
Rotterdam
3062 PA
Netherlands

Trial participating centre

Artsengroep Persoonsstraat
3071 EK
Netherlands

Trial participating centre

M.C. Verbeek-Poot, huisarts
3078 XS
Netherlands

Trial participating centre

Huisartspraktijk Jansen
3071 JP
Netherlands

Trial participating centre

Gezondheidscentrum Nieuwe Westen
3022 SG
Netherlands

Trial participating centre

Praktijk Mozaiek
3074 LB
Netherlands

Trial participating centre

Gezondheidscentrum Tarwezigt
3081 CN
Netherlands

Trial participating centre

Huisartspraktijk Nusteling (voorheen Harmsen en Lo Fo Wong)
3082 KC
Netherlands

Trial participating centre

Huisartspraktijk Bijl
3076 KV
Netherlands

Trial participating centre

Gezondheidscentrum Beverwaard
3077 JS
Netherlands

Trial participating centre

Gezondheidscentrum Randweg
3074 BJ
Netherlands

Trial participating centre

Gezondheidscentrum Sint-Mariastraat
3014 SH
Netherlands

Sponsor information

Organisation

Erasmus School of Health Policy and Management

Sponsor details

Burg. Oudlaan 50
Rotterdam
3062 PA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

ZonMw

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Results and Publications

Publication and dissemination plan

Study protocol (including analysis plan) is available (in Dutch only) by contacting Dr Choté.

Plans for publications (in peer reviewed journals):
1. Study design (intended publication date: end of 2018)
2. Results of cost-effectiveness study (intended publication date: end of 2018/early 2019)

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anushka Choté (chote@eshpm.eur.nl). Data: baseline (T0) and follow up (T1) data at patient level, based on primary and secondary outcome measures and demographic characteristics. As no explicit consent from participants was obtained for sharing the data, data can be made available only in close collaboration and under supervision of project leader (or representative). Data dictionaries are available upon request. Applicants should specify which data are necessary for their intended analyses. From this dedicated data sets will be constructed.

Intention to publish date

31/12/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

- Energy in Balance: an intervention study aiming at migrant women that frequently attend general practitioners with medically unexplained somatic complaints. Research protocol of a RCT. Poster presented at 4th Conference on Migrant and Ethnic Minority Health in Europe, Milan, 21-23 June 2012
- Energy in Balance: an intervention study aiming at migrant women that frequently attend general practitioners with medically unexplained somatic complaints. Research protocol and first results - poster presented at 5th Conference on Migrant and Ethnic Minority Health in Europe, Granada, 9-12 April 2014
- Cost effectiveness of an intervention aiming at migrant women with unexplained somatic complaints. Poster presented at 8th Public Health Conference; Milan, 14-17 Oct. 2015

Publication citations

Additional files

Editorial Notes