FallsFFC23NCT05889910

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

A study testing Health education workshop in people with Falls and Fear of Falling, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Falls, Fear of Falling, Nursing
What is being tested?: Health education workshop
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 163 participants
Where: 1 siteSpain
Study dates: 13 Feb 2023to 30 Nov 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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).

Who cannot join

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).

Show all 9Show fewer

Hospitalization during the recruitment period or forecast admissions scheduled during the study period.
Institutionalized patients or with frequent changes of address.
Refusal to participate.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Centro de Salud Sector III.
Getafe, Madrid, 28905

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions: Falls, Fear of Falling, Nursing
Being tested: Health education workshop
Keywords: Health Primary Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Health education workshopProcedure or surgery
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.

Study groups in NCT05889910
Study group	Role	What they receive
Intervention Group	Experimental	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. Receives: Procedure: Health education workshop
Control Group	Active comparator	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. Receives: Procedure: Health education workshop

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Number of participants with post-intervention Falls.
Post-intervention Falls (yes or no)
Measured: One month post-intervention.
Number of participants with post-intervention Falls.
Post-intervention Falls (yes or no)
Measured: Six months post intervention.
Number of participants with post-intervention Falls.
Post-intervention Falls (yes or no)
Measured: 12 months post intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Feb 202330 Nov 2024

First posted5 Jun 2023
Study start13 Feb 2023
Primary completion30 May 2024
Study completion30 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for FallsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two-arm, parallel, multicenter, cluster-randomized clinical trial, 1:1 participant distribution ratio.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 163 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05889910
Sponsor's protocol ID: FEARFALL_CARE
Acronym: FFC23
Status last verified: Nov 2024
First submitted: 8 May 2023
Last updated: 26 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The databases will be available to any interested researcher.

Publications

Schoene D, Heller C, Aung YN, Sieber CC, Kemmler W, Freiberger E. A systematic review on the influence of fear of falling on quality of life in older people: is there a role for falls? Clin Interv Aging. 2019 Apr 24;14:701-719. doi: 10.2147/CIA.S197857. eCollection 2019.
PubMed 31190764
Liu TW, Ng GYF, Chung RCK, Ng SSM. Cognitive behavioural therapy for fear of falling and balance among older people: a systematic review and meta-analysis. Age Ageing. 2018 Jul 1;47(4):520-527. doi: 10.1093/ageing/afy010.
PubMed 29471428
Tomita Y, Arima K, Tsujimoto R, Kawashiri SY, Nishimura T, Mizukami S, Okabe T, Tanaka N, Honda Y, Izutsu K, Yamamoto N, Ohmachi I, Kanagae M, Abe Y, Aoyagi K. Prevalence of fear of falling and associated factors among Japanese community-dwelling older adults. Medicine (Baltimore). 2018 Jan;97(4):e9721. doi: 10.1097/MD.0000000000009721.
PubMed 29369207
Makino K, Makizako H, Doi T, Tsutsumimoto K, Hotta R, Nakakubo S, Suzuki T, Shimada H. Impact of fear of falling and fall history on disability incidence among older adults: Prospective cohort study. Int J Geriatr Psychiatry. 2018 Apr;33(4):658-662. doi: 10.1002/gps.4837. Epub 2017 Dec 12.
PubMed 29231272
Lavedan A, Viladrosa M, Jurschik P, Botigue T, Nuin C, Masot O, Lavedan R. Fear of falling in community-dwelling older adults: A cause of falls, a consequence, or both? PLoS One. 2018 Mar 29;13(3):e0194967. doi: 10.1371/journal.pone.0194967. eCollection 2018.
PubMed 29596521
Lee S, Oh E, Hong GS. Comparison of Factors Associated with Fear of Falling between Older Adults with and without a Fall History. Int J Environ Res Public Health. 2018 May 14;15(5):982. doi: 10.3390/ijerph15050982.
PubMed 29757960
Vitorino LM, Teixeira CA, Boas EL, Pereira RL, Santos NO, Rozendo CA. Fear of falling in older adults living at home: associated factors. Rev Esc Enferm USP. 2017 Apr 10;51:e03215. doi: 10.1590/S1980-220X2016223703215. English, Portuguese.
PubMed 28403369
Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
PubMed 2229948
Hughes CC, Kneebone II, Jones F, Brady B. A theoretical and empirical review of psychological factors associated with falls-related psychological concerns in community-dwelling older people. Int Psychogeriatr. 2015 Jul;27(7):1071-87. doi: 10.1017/S1041610214002701. Epub 2015 Jan 30.
PubMed 25633917
Kim JH, Bae SM. Association between Fear of Falling (FOF) and all-cause mortality. Arch Gerontol Geriatr. 2020 May-Jun;88:104017. doi: 10.1016/j.archger.2020.104017. Epub 2020 Jan 27.
PubMed 32044524
Lach HW, Parsons JL. Impact of fear of falling in long term care: an integrative review. J Am Med Dir Assoc. 2013 Aug;14(8):573-7. doi: 10.1016/j.jamda.2013.02.019. Epub 2013 Apr 16.
PubMed 23602257
Alarcon T, Gonzalez-Montalvo JI, Otero Puime A. [Assessing patients with fear of falling. Does the method use change the results? A systematic review]. Aten Primaria. 2009 May;41(5):262-8. doi: 10.1016/j.aprim.2008.09.019. Spanish.
PubMed 19464526
Yardley L, Beyer N, Hauer K, Kempen G, Piot-Ziegler C, Todd C. Development and initial validation of the Falls Efficacy Scale-International (FES-I). Age Ageing. 2005 Nov;34(6):614-9. doi: 10.1093/ageing/afi196.
PubMed 16267188
Kempen GI, Yardley L, van Haastregt JC, Zijlstra GA, Beyer N, Hauer K, Todd C. The Short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. Age Ageing. 2008 Jan;37(1):45-50. doi: 10.1093/ageing/afm157. Epub 2007 Nov 20.
PubMed 18032400
Lee J, Choi M, Kim CO. Falls, a fear of falling and related factors in older adults with complex chronic disease. J Clin Nurs. 2017 Dec;26(23-24):4964-4972. doi: 10.1111/jocn.13995. Epub 2017 Oct 2.
PubMed 28793363

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Falls trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of the Implementation of a Standardized Care Plan to Improve Fear of Falling and Incidence of Falls. FEARFALL_CARE Study
ClinicalTrials.gov ID: NCT05889910
Acronym / sponsor ID: FFC23 / FEARFALL_CARE
Conditions: Falls, Fear of Falling, Nursing
Keywords: Health Primary Care
Study type: Interventional
Recruitment status: Completed
Enrolment: 163 participants (actual)
Lead sponsor: Gerencia de Atención Primaria, MadridOther government
Collaborators: Universidad Complutense de Madrid
Study start: 13 Feb 2023 (actual)
Primary completion: 30 May 2024 (actual)
Study completion: 30 Nov 2024 (actual)
First posted: 5 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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?

Detailed description

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Two-arm, parallel, multicenter, cluster-randomized clinical trial, 1:1 participant distribution ratio.

Arm	Type	Receives
Intervention Group	Experimental	Procedure: Health education workshopThe 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.
Control Group	Active comparator	Procedure: Health education workshopThe 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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (9 listed)

People with the following medical diagnoses or health problems (coded according to the International Classification of Diseases (ICD - 10):
Hospitalization during the recruitment period or forecast admissions scheduled during the study period.
Institutionalized patients or with frequent changes of address.
Refusal to participate.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Health education workshopThe 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.	Procedure or surgery	Control Group, Intervention Group

Primary outcome

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.
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.
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.

3 secondary outcomes

Number of participants with post-intervention Falls.
Time frame: One month post-intervention.
Number of participants with post-intervention Falls.
Time frame: Six months post intervention.
Number of participants with post-intervention Falls.
Time frame: 12 months post intervention.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
Background: PubMed 31190764Schoene D, Heller C, Aung YN, Sieber CC, Kemmler W, Freiberger E. A systematic review on the influence of fear of falling on quality of life in older people: is there a role for falls? Clin Interv Aging. 2019 Apr 24;14:701-719. doi: 10.2147/CIA.S197857. eCollection 2019.
Background: PubMed 29471428Liu TW, Ng GYF, Chung RCK, Ng SSM. Cognitive behavioural therapy for fear of falling and balance among older people: a systematic review and meta-analysis. Age Ageing. 2018 Jul 1;47(4):520-527. doi: 10.1093/ageing/afy010.
Background: PubMed 29369207Tomita Y, Arima K, Tsujimoto R, Kawashiri SY, Nishimura T, Mizukami S, Okabe T, Tanaka N, Honda Y, Izutsu K, Yamamoto N, Ohmachi I, Kanagae M, Abe Y, Aoyagi K. Prevalence of fear of falling and associated factors among Japanese community-dwelling older adults. Medicine (Baltimore). 2018 Jan;97(4):e9721. doi: 10.1097/MD.0000000000009721.
Background: PubMed 29231272Makino K, Makizako H, Doi T, Tsutsumimoto K, Hotta R, Nakakubo S, Suzuki T, Shimada H. Impact of fear of falling and fall history on disability incidence among older adults: Prospective cohort study. Int J Geriatr Psychiatry. 2018 Apr;33(4):658-662. doi: 10.1002/gps.4837. Epub 2017 Dec 12.
Background: PubMed 29596521Lavedan A, Viladrosa M, Jurschik P, Botigue T, Nuin C, Masot O, Lavedan R. Fear of falling in community-dwelling older adults: A cause of falls, a consequence, or both? PLoS One. 2018 Mar 29;13(3):e0194967. doi: 10.1371/journal.pone.0194967. eCollection 2018.
Background: PubMed 29757960Lee S, Oh E, Hong GS. Comparison of Factors Associated with Fear of Falling between Older Adults with and without a Fall History. Int J Environ Res Public Health. 2018 May 14;15(5):982. doi: 10.3390/ijerph15050982.
Background: PubMed 28403369Vitorino LM, Teixeira CA, Boas EL, Pereira RL, Santos NO, Rozendo CA. Fear of falling in older adults living at home: associated factors. Rev Esc Enferm USP. 2017 Apr 10;51:e03215. doi: 10.1590/S1980-220X2016223703215. English, Portuguese.
Background: PubMed 2229948Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
Background: PubMed 25633917Hughes CC, Kneebone II, Jones F, Brady B. A theoretical and empirical review of psychological factors associated with falls-related psychological concerns in community-dwelling older people. Int Psychogeriatr. 2015 Jul;27(7):1071-87. doi: 10.1017/S1041610214002701. Epub 2015 Jan 30.
Background: PubMed 32044524Kim JH, Bae SM. Association between Fear of Falling (FOF) and all-cause mortality. Arch Gerontol Geriatr. 2020 May-Jun;88:104017. doi: 10.1016/j.archger.2020.104017. Epub 2020 Jan 27.
Background: PubMed 23602257Lach HW, Parsons JL. Impact of fear of falling in long term care: an integrative review. J Am Med Dir Assoc. 2013 Aug;14(8):573-7. doi: 10.1016/j.jamda.2013.02.019. Epub 2013 Apr 16.
Background: PubMed 19464526Alarcon T, Gonzalez-Montalvo JI, Otero Puime A. [Assessing patients with fear of falling. Does the method use change the results? A systematic review]. Aten Primaria. 2009 May;41(5):262-8. doi: 10.1016/j.aprim.2008.09.019. Spanish.
Preocupación a caer validación de un instrumento de medición en personas mayores chilenas que viven en la comunidadLink provided by the sponsor.
Individual participant dataSharing planned: Yes. The databases will be available to any interested researcher.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Health education workshop in people with Falls and Fear of Falling, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Short Falls Efficacy Scale-International adapted to Spanish. (time frame: One month post intervention.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05889910, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.