Effectiveness of the follow-up of depressed patients by nurses

ISRCTN ISRCTN08808171
DOI https://doi.org/10.1186/ISRCTN08808171
Secondary identifying numbers PI061281
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

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study acronymMADEIRA
Study objectives1. 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) studiedMajor depression
InterventionHalf 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 typeOther
Primary outcome measure1. 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
Secondary outcome measures1. 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
Overall study start date01/01/2008
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants460
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2008
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Spain

Study participating centre

Lope de Vega 138
Barcelona
08005
Spain

Sponsor information

Jordi Gol i Gurina Primary Care Research Institute (IDIAP Jordi Gol i Gurina) (Spain)
Government

Gran Via de les Corts Catalanes
587 àtic
Barcelona
08007
Spain

http://www.idiapjgol.org/
ROR logo https://ror.org/0370bpp07

Funders

Funder type

Government

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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