Effectiveness of an implementation strategy of Clinical Practice Guideline for patients with anxiety disorders in Primary Care
| ISRCTN | ISRCTN83365316 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83365316 |
| Secondary identifying numbers | PI09/90304 |
- Submission date
- 18/06/2010
- Registration date
- 04/08/2010
- Last edited
- 29/12/2020
- 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
Mrs M Eugenia Tello
Scientific
Scientific
Avda. de los Pinos, 30.
Leganés
28914
Spain
Study information
| Study design | Multicentre cluster randomised 2 arm open label controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | Cluster randomized trial for evaluate the effectiveness of an implementation strategy of a clinical practice guideline for patients with anxiety disorders |
| Study acronym | GRITA |
| Study objectives | The percentage of patients with a decrease of 2 or more points in the Goldberg Anxiety Scale after 6 months, will be 20% higher in those that were involved in the focused organisational strategy over those that werent involved in it. |
| Ethics approval(s) | The Committee of Ethical Investigation of the 9th Madrid Health Area approved on the 29th of April 2010 |
| Health condition(s) or problem(s) studied | Generalised anxiety disorder, panic disorder and panic attacks |
| Intervention | 1. Control group: 1.1. The Clinical Practice Guideline (CPG) will be included on the official working place website 1.2. The CPG will be presented in a formative session of 2 hours of length to which will be invited to assist 1 or 2 members of each one of the 22 Health Centres involved in the study 2. Intervention group: 2.1. They will also receive an special formative session of 2 hours of length focused on the professionals with the protocol of intervention 2.2. They will receive special educational material as information sheets for patients, quick guides, etc. 2.3. A local opinion leader will be chosen on each team as the responsible person for the CPG 2.4. A defined system for reminding, audit and feedback will be developed to give back information about the intermediate results of the study at 3 and 6 months of the beginning. |
| Intervention type | Other |
| Primary outcome measure | 1. Variation of 2 or more points in the Goldberg Anxiety Scale 2. Evaluative criteria 2.1. 4 or more affirmative responses in the Anxiety subscale 2.2. 2 or more affirmative responses in the Depression subscale Outcomes will be measured at baseline, 6 and 12 months. |
| Secondary outcome measures | 1. Compliance with the Guideline recommendations on treatment 2. Information and referrals to Mental Health Services Outcomes will be measured at baseline, 6 and 12 months in data collecting notebooks |
| Overall study start date | 15/09/2010 |
| Completion date | 15/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Sample size adjusted for design effect = 296 (148 in each arm) |
| Key inclusion criteria | 1. Patients older than 18 2. Diagnosed as generalised anxiety disorder, panic disorder and panic attacks by Diagnostic and Statistical Manual of Mental Disorders 4th edition (text revision) (DSM-IV-TR) 3. Signed informed consent |
| Key exclusion criteria | 1. Subjects that have been diagnosed of one of the following types of anxiety: 1.1. Post-traumatic stress disorders 1.2. Acute stress disorders 1.3. drug-related anxiety disorders 1.4. Anxiety disorders due to a medical or a mental illness 2. Subjects not able to read or understand Spanish language 3. Subjects that will not stay living on the Health Area in the next year after their inclusion on the study 4. Institutionalised or immobilised patients |
| Date of first enrolment | 15/09/2010 |
| Date of final enrolment | 15/09/2012 |
Locations
Countries of recruitment
- Spain
Study participating centre
Avda. de los Pinos, 30.
Leganés
28914
Spain
28914
Spain
Sponsor information
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Hospital/treatment centre
Hospital/treatment centre
General Sub-Department for the Evaluation and Promotion of Research
(Subdirección General Evaluación y Fomento de la Investigación)
Monforte de Lemos, 5
Madrid
28029
Spain
"ROR" |
https://ror.org/00ca2c886 |
|---|
Funders
Funder type
Hospital/treatment centre
Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) - Spanish Ministry of Health Supporting Investigation Department (ref: PI09/90304)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/12/2011 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: Publication reference added.
