Effectiveness of the Implementation of a Standardized Care Plan to Improve Fear of Falling and Incidence of Falls — FFC23  

Nursing Clinical Trial

Official title: Effectiveness of the Implementation of a Standardized Care Plan to Improve the Fear of Falling and the Incidence of Falls in Older People Living in the Community. Cluster Randomized Clinical Trial. FEARFALL_CARE Study

Status Active, not recruiting

Clinical Trial Summary

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:

• Is it possible to reduce the fear of falling in patients over 65 years of age through an educational intervention in primary care?

• Is it possible to reduce falls in patients older than 65 years through an educational intervention in primary care?

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.

Clinical Trial Description

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:

• Determine the score of the short FES-I questionnaire in people over 65 years of age who have completed the care plan and in those who have followed usual clinical practice.

• Analyze the relationship between the sociodemographic variables of the patients and the clinical and functional variables with the score of the short FES-I questionnaire, both in the control and intervention groups.

• Analyze the relationship between the sociodemographic variables of the patients and the clinical and functional variables with the incidence of falls in both the control and intervention groups.

• Analyze the satisfaction of the application of the proposed standardized care plan.

• Analyze the safety of the application of the proposed standardized care plan.

• Analyze the effect of the intervention (measured through the mean difference in the short FES-I questionnaire) on the functional variables, the emotional state (anxiety and depression, measured through the Generalized Anxiety Disorder-7 (GAD- 7) and Patient Health Questionnaire-8 (PHQ-8)), self-care capacity (through the Self-Care Agency Capacity-Reduced scale) and perception of health.

• Characterize (by age, sex, functional status, clinical and emotional situation) the patients who suffered falls.

• Evaluate the feasibility and acceptability by patients and professionals of carrying out a Randomized Clinical Trial (RCT) to reduce the fear of falling and the incidence of falls by carrying out a standardized care plan that combines physical exercise and cognitive therapy. behavioral. ;

Related Conditions & MeSH terms

• Falls
• Fear of Falling
• Nursing

• NCT number: NCT05889910
• Study type: Interventional
• Source: Gerencia de Atención Primaria, Madrid
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2023
• Completion date: May 3, 2024