Effectiveness of the follow-up of depressed patients by nurses

ISRCTN	ISRCTN08808171
DOI	https://doi.org/10.1186/ISRCTN08808171
Protocol serial number	PI061281
Sponsor	Jordi Gol i Gurina Primary Care Research Institute (IDIAP Jordi Gol i Gurina) (Spain)
Funder	Carlos III Health Institute of the Spanish Ministry of Health and Consumption (Fondo de Investigación Sanitaria, Instituto de Salud Carlos III, Ministerio de Sanidad y Consumo), Health Research Fund (Spain)

Submission date: 27/11/2007
Registration date: 18/12/2007
Last edited: 18/12/2007

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

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr María Isabel Fernández San Martín
Scientific

Lope de Vega 138
Barcelona
08005
Spain

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MADEIRA
Study objectives	1. The average depressive symptoms at the end of six months of follow-up among the group of depression patients treated by the primary care nurse and the group treated by the family doctor do not exceed the difference of 2.5 on the BDI scale, which is considered a difference not clinically relevant. 2. There will be no significant difference in change in the quality of life between the two groups. 3. Level of satisfaction will be similar in both groups, or greater among patients followed by nurses than the participants who are treated by the doctors 4. Adherence to treatment will be similar in both groups, or higher in patients followed by the nurses
Ethics approval(s)	Approved by the Research Ethics Committee of the Jordi Gol i Gurina Primary Care Research Institute (IDIAP), Barcelona, on 4 July 2006 (ref: P06/39)
Health condition(s) or problem(s) studied	Major depression
Intervention	Half of the participants will be allocated to the intervention group and another half into the control group. This trial involves 23 doctors and 23 nurses from 12 primary care teams in Barcelona. Intervention group: Implementation of a depression management protocol, based on evidence-based clinical guidelines, by the primary care nurse. This protocol includes pharmacological treatment with fluoxetine or another Selective Serotonin Re-uptake Inhibitor (SSRI), and the participants will have at least 6 appointments with the nurses during the 6 months of follow-up. At each visit, each patient will be informed about the disease and pharmacological treatment. In addition, the nurse will ask the patient about changes in mood and try to enhance compliance. Nurses will also provide emotional support. If the patient does not improve, he will be referred to his doctor. Control group: Six-month follow-up by family doctors. Family doctors will provides usual care management. They can prescribe fluoxetine or another SSRI. Participants will have at least 6 appointments with their doctor during the 6 months of follow-up.
Intervention type	Other
Primary outcome measure(s)	1. Differences between groups in the average of decrease in depression symptoms, measured by BDI at 6 months 2. Increase in quality of life, measured by the 12-item Short Form health survey (SF-12) at 6 months 3. Increase in satisfaction with the professional, measured by the satisfaction questionnaire of Baker at 6 months
Key secondary outcome measure(s)	1. Percentage of acceptance of the intervention (comparison of the two groups): patient satisfaction and losses that occur at different times of follow-up 2. Average of differences between the two groups with respect to: 2.1. Frequency and duration of visits 2.2. Referrals 2.3. Drug treatment 3. Comparison of adherence to treatment between the two groups
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	460
Key inclusion criteria	1. Patients between 25 and 70 years of age 2. Rating of 20 or more points in the Beck Depression Inventory Scale (BDI) 3. Whose family practitioner thinks they suffer from depression and they need to initiate anti-depressant treatment
Key exclusion criteria	1. Pregnancy or breastfeeding 2. Background of severe psychiatric disorders: psychosis, paranoia, severe personality disorders, delusional thoughts 3. Existence of suicidal ideation or attempts 4. Two or more episodes of major depression, or one or more episodes that might require hospitalization 5. Patients who have received antidepressant medication in the past year 6. Patients with mental health problems who have been referred to psychiatric specialists for these reasons 7. Substance abuse and/or drugs 8. Treatment for Parkinson's disease or epilepsy 9. Temporal residents (plan to move in the next six months) 10. Unable to communicate in Spanish or Catalan languages
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Spain

Study participating centre

Lope de Vega 138

Barcelona
08005
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan