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

Sponsor
Gerencia de Atención Primaria, Madrid (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05889910
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
14.6
Anticipated Duration (Months)
10.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Health education workshop
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two-arm, parallel, multicenter, cluster-randomized clinical trial, 1:1 participant distribution ratio.Two-arm, parallel, multicenter, cluster-randomized clinical trial, 1:1 participant distribution ratio.
Masking:
Single (Outcomes Assessor)
Masking Description:
To avoid selection bias, professionals were blinded to group assignment at the time of patient recruitment. Once everyone had signed the informed consent, a cluster group was assigned to each of the 10 participating Health Centers.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 13, 2023
Actual Primary Completion Date :
May 3, 2023
Anticipated Study Completion Date :
May 3, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Short Falls Efficacy Scale-International adapted to Spanish. [One month post intervention.]

    (FES-I) Range 7-28. 11 or more points: indicates fear of falling.

  2. Short Falls Efficacy Scale-International adapted to Spanish. [Six months post intervention.]

    (FES-I)Range 7-28. 11 or more points: indicates fear of falling.

  3. 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

  1. Number of participants with post-intervention Falls. [One month post-intervention.]

    Post-intervention Falls (yes or no)

  2. Number of participants with post-intervention Falls. [Six months post intervention.]

    Post-intervention Falls (yes or no)

  3. Number of participants with post-intervention Falls. [12 months post intervention.]

    Post-intervention Falls (yes or no)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro de Salud Sector III. Getafe Madrid Spain 28905

Sponsors and Collaborators

  • Gerencia de Atención Primaria, Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Nuria Alcolea Ruiz, Enfermera Especialista en Atención Familiar y Comunitaria. Master Oficial de Investigación en Cuidados de Salud. Doctoranda en el Programa de Cuidados en Salud de la Universidad Complutense de Madrid., Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT05889910
Other Study ID Numbers:
  • FEARFALL_CARE
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nuria Alcolea Ruiz, Enfermera Especialista en Atención Familiar y Comunitaria. Master Oficial de Investigación en Cuidados de Salud. Doctoranda en el Programa de Cuidados en Salud de la Universidad Complutense de Madrid., Gerencia de Atención Primaria, Madrid
Health Primary Care

Study Results

No Results Posted as of Jun 5, 2023