An interventional study of Health education workshop in Falls, Fear of Falling and Nursing, sponsored by Gerencia de Atención Primaria, Madrid. Completed at 1 site in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Gerencia de Atención Primaria, Madrid · Not applicable, Interventional, and Treatment
The objective of this clinical trial is to evaluate the effectiveness of the implementation of a standardized care plan to reduce the fear of falling in people over 65 years of age with fear of falling who live in the community.
The main questions it aims to answer are:
Half of the participants will receive an educational intervention consisting of 6 two-hour sessions at the Health Center. The comparison group will follow the usual clinical practice recommended by the Primary Care Assistance Management of the Community of Madrid. It is intended to observe if there are differences in the fear of falling and falls in both groups.
General objective: To evaluate the effectiveness of the implementation of a standardized care plan to reduce the fear of falling in people over 65 years of age with fear of falling who live in the community.
Specific objectives:
Gerencia de Atención Primaria, Madrid is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
People with the following medical diagnoses or health problems (coded according to the International Classification of Diseases (ICD - 10):
- Diagnosis of mental, behavioral and neurodevelopmental disorders: delirium, dementia, amnestic disorders and other cognitive disorders (F05.0; F05.9; F00; F02.8; F03; F04; R41.3; F06.9). Mental disorders due to general medical condition, unclassified in other sections (F06.1; F07.0; F09). Schizophrenia and other psychotic disorders (F20; F22; F23; F24; F29).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention will consist of 5 initial sessions, plus a reinforcement session at 6 months. The sessions will last 2 hours and will preferably be distributed one day a week. To this end, nursing interventions will be included to improve the knowledge, skills and attitudes of the participants regarding the improvement of their functional capacity, the prevention of falls and their preventive measures, as well as the improvement in the management of anxiety and coping with the fear of falling and falls. The activities carried out during the intervention have been extracted from standardized nursing interventions through the Nursing Interventions Classification (NIC). The following interventions and activities will be addressed: 1665, 5612, 6490, 6486, 4700, 5820 and 5230.
Procedure: Health education workshop
The control group intervention will be the usual clinical practice offered by the patient's nurse in the Primary Care setting during the duration of the study. The usual clinical practice is based on attention to the user's demands, as well as the performance of interventions that can influence falls and/or the fear of falling. These activities or interventions are based on the Services of the Standardized Service Portfolio of the Community of Madrid (Updated as of January 28, 2022) in which these patients are included due to age or as a consequence of their chronic pathology.
Procedure: Health education workshop
The intervention will consist of 5 initial sessions, plus a reinforcement session at 6 months. The sessions will last 2 hours and will preferably be distributed one day a week. The objective of the intervention is to reduce the fear of falling and falls in people over 65 years of age who live in the community. To this end, nursing interventions will be included to improve the knowledge, skills and attitudes of the participants regarding the improvement of their functional capacity, the prevention of falls and their preventive measures, as well as the improvement in the management of anxiety and coping with the fear of falling and falls. The activities carried out during the intervention have been extracted from standardized nursing interventions through the Nursing Interventions Classification (NIC). The following interventions and activities will be addressed: 1665, 5612, 6490, 6486, 4700, 5820 and 5230.
Short Falls Efficacy Scale-International adapted to Spanish.
(FES-I) Range 7-28. 11 or more points: indicates fear of falling.
Time frame: One month post intervention.
Short Falls Efficacy Scale-International adapted to Spanish.
(FES-I)Range 7-28. 11 or more points: indicates fear of falling.
Time frame: Six months post intervention.
Short Falls Efficacy Scale-International adapted to Spanish.
(FES-I). Range 7-28. 11 or more points: indicates fear of falling.
Time frame: 12 months post intervention.
Number of participants with post-intervention Falls.
Post-intervention Falls (yes or no)
Time frame: One month post-intervention.
Number of participants with post-intervention Falls.
Post-intervention Falls (yes or no)
Time frame: Six months post intervention.
Number of participants with post-intervention Falls.
Post-intervention Falls (yes or no)
Time frame: 12 months post intervention.
Plan to share: Yes — The databases will be available to any interested researcher.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Study protocol, Informed Consent Form: available since today. Statistical Analysis Plan: avaliable since may 2024. Clinical Study Report and Analytic Code: avaliable since october 2024.
Access criteria: Principal investigators of other projects approved by a Clinical Research Ethics Committee will be able to access. They will have access to the previously explained data. The data will be accessible once the project has been published in scientific journals.
Ran from Feb 2023 to primary completion in May 2024, 15 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Gerencia de Atención Primaria, Madrid