Clinical trial NCT05889910: Effectiveness of the Implementation of a Standardized Care Plan to Improve Fear of Falling and Incidence of Falls
Official title: Effectiveness of the Implementation of a Standardized Care Plan to Improve Fear of Falling and Incidence of Falls. FEARFALL_CARE Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Falls
Fear of Falling
Nursing
Keywords: Health Primary Care
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
Collaborators: name: Universidad Complutense de Madrid
First posted: 2023-06-05
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel, multicenter, cluster-randomized clinical trial, 1:1 participant distribution ratio.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Short Falls Efficacy Scale-International adapted to Spanish.
timeFrame: One month post intervention.
measure: Short Falls Efficacy Scale-International adapted to Spanish.
timeFrame: Six months post intervention.
measure: Short Falls Efficacy Scale-International adapted to Spanish.
timeFrame: 12 months post intervention.
Secondary outcomes:
measure: Number of participants with post-intervention Falls.
timeFrame: One month post-intervention.
measure: Number of participants with post-intervention Falls.
timeFrame: Six months post intervention.
measure: Number of participants with post-intervention Falls.
timeFrame: 12 months post intervention.
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Centro de Salud Sector III.
state: Madrid
Study officials:
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