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

August 20, 2025 updated by: Nuria Alcolea Ruiz, Gerencia de Atención Primaria, Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Centro de Salud Sector III.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

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 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.
Active Comparator: Control Group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Falls Efficacy Scale-International adapted to Spanish.
Time Frame: One month post intervention.
(FES-I) Range 7-28. 11 or more points: indicates fear of falling.
One month post intervention.
Short Falls Efficacy Scale-International adapted to Spanish.
Time Frame: Six months post intervention.
(FES-I)Range 7-28. 11 or more points: indicates fear of falling.
Six months post intervention.
Short Falls Efficacy Scale-International adapted to Spanish.
Time Frame: 12 months post intervention.
(FES-I). Range 7-28. 11 or more points: indicates fear of falling.
12 months post intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with post-intervention Falls.
Time Frame: One month post-intervention.
Post-intervention Falls (yes or no)
One month post-intervention.
Number of participants with post-intervention Falls.
Time Frame: Six months post intervention.
Post-intervention Falls (yes or no)
Six months post intervention.
Number of participants with post-intervention Falls.
Time Frame: 12 months post intervention.
Post-intervention Falls (yes or no)
12 months post intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gerencia de Atención Primaria, Madrid

Collaborators

Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 5, 2023

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FEARFALL_CARE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The databases will be available to any interested researcher.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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