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

Nursing Clinical Trial

— FFC23  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05889910
• Other study ID #: FEARFALL_CARE
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: May 3, 2024

Study information

• Verified date: May 2023
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: May 3, 2024
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Falls
• Fear of Falling
• Nursing

Intervention

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.

Locations

Country	Name	City	State
Spain	Centro de Salud Sector III.	Getafe	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (24)

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Alcolea-Ruiz N, Alcolea-Ruiz S, Esteban-Paredes F, Beamud-Lagos M, Villar-Espejo MT, Perez-Rivas FJ. [Prevalence of fear of falling and related factors in community-dwelling older people]. Aten Primaria. 2021 Feb;53(2):101962. doi: 10.1016/j.aprim.2020.11.003. Epub 2021 Jan 11. Spanish. — View Citation

Chang HT, Chen HC, Chou P. Factors Associated with Fear of Falling among Community-Dwelling Older Adults in the Shih-Pai Study in Taiwan. PLoS One. 2016 Mar 2;11(3):e0150612. doi: 10.1371/journal.pone.0150612. eCollection 2016. — View Citation

Chua CHM, Jiang Y, Lim S, Wu VX, Wang W. Effectiveness of cognitive behaviour therapy-based multicomponent interventions on fear of falling among community-dwelling older adults: A systematic review and meta-analysis. J Adv Nurs. 2019 Dec;75(12):3299-3315. doi: 10.1111/jan.14150. Epub 2019 Aug 27. — View Citation

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Kruisbrink M, Delbaere K, Kempen GIJM, Crutzen R, Ambergen T, Cheung KL, Kendrick D, Iliffe S, Zijlstra GAR. Intervention Characteristics Associated With a Reduction in Fear of Falling Among Community-Dwelling Older People: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Gerontologist. 2021 Aug 13;61(6):e269-e282. doi: 10.1093/geront/gnaa021. Erratum In: Gerontologist. 2022 Nov 30;62(10):e629. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Falls Efficacy Scale-International adapted to Spanish.	(FES-I) Range 7-28. 11 or more points: indicates fear of falling.	One month post intervention.
Primary	Short Falls Efficacy Scale-International adapted to Spanish.	(FES-I)Range 7-28. 11 or more points: indicates fear of falling.	Six months post intervention.
Primary	Short Falls Efficacy Scale-International adapted to Spanish.	(FES-I). Range 7-28. 11 or more points: indicates fear of falling.	12 months post intervention.
Secondary	Number of participants with post-intervention Falls.	Post-intervention Falls (yes or no)	One month post-intervention.
Secondary	Number of participants with post-intervention Falls.	Post-intervention Falls (yes or no)	Six months post intervention.
Secondary	Number of participants with post-intervention Falls.	Post-intervention Falls (yes or no)	12 months post intervention.

External Links

•   Preocupación a caer validación de un instrumento de medición en personas mayores chilenas que viven en la comunidad