Nursing Clinical Trial
— FFC23Official 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
Verified date | May 2023 |
Source | Gerencia de Atención Primaria, Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Centro de Salud Sector III. | Getafe | Madrid |
Lead Sponsor | Collaborator |
---|---|
Gerencia de Atención Primaria, Madrid |
Spain,
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* Note: There are 24 references in all — Click here to view all references
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. |
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