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

Not Applicable

Completed

• Conditions: Falls; Fear of Falling; Nursing

• Registration Number: NCT05889910
• Lead Sponsor: Gerencia de Atención Primaria, Madrid

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-02-13
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-05
• Primary Completion: 2024-05-30
• Status Verified: 2024-11
• Study Completion: 2024-11-30
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• People over 65 years of age on the start date of the study.
• People who are independent for the basic activities of daily living (ABVD) or who have mild functional dependence (Barthel Index score ≥ 60 and Short Physical Performance Battery (SPPB) ≥ 4),
• independent for ambulation (they walk 45m without help or with a cane),
• without cognitive impairment (Mini-Mental State Examination ((MMSE) ≥ 24).
• and with fear of falling (Short FES-I ≥ 11).

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).

  • Diagnosis of neurodegenerative diseases: Parkinson's disease (G20); Alzheimer's disease (G30); Multiple sclerosis (G35); Myasthenia gravis and other myoneuronal disorders (G70).
  • Diagnosis of blindness and low vision (H54).
  • Diagnosis of conductive and sensorineural hearing loss bilateral or uncorrected with a hearing aid (H90.0; H90.2; H90.5; H90.6; H90.8) and other types of hearing loss, (H83.3; H91) whenever they make it difficult for the participants to understand.
  • Diagnosis of acute ischemic heart diseases and cerebrovascular diseases in the last 1 year (I20-I24; I60-I63; I67; I68).

• Hospitalization during the recruitment period or forecast admissions scheduled during the study period.

• Institutionalized patients or with frequent changes of address.

• Refusal to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Short Falls Efficacy Scale-International adapted to Spanish.	12 months post intervention.	(FES-I). Range 7-28. 11 or more points: indicates fear of falling.

Secondary Outcome Measures

Name	Time	Method
Number of participants with post-intervention Falls.	12 months post intervention.	Post-intervention Falls (yes or no)

Trial Locations

Locations (1)

Centro de Salud Sector III.; 🇪🇸 Getafe, Madrid, Spain