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Fall Prevention Pathways

11 de setembro de 2026 atualizado por: Madeleine Eve Hackney, Emory University

Feasibility, Acceptability and Adherence of the Fall Prevention Pathways With Remote Monitoring

Falls are a leading cause of injury and loss of independence in older adults, with evidence supporting exercise-based interventions and remote monitoring as effective strategies for reducing fall risk. However, adherence and engagement with such programs remain significant challenges.

This study builds on prior research demonstrating the feasibility of digital health interventions in rehabilitation and extends it to a structured, remotely monitored Fall Prevention Pathway (FPP). Preliminary work in digital rehabilitation has shown positive engagement and clinical outcomes, supporting the need for further exploration of feasibility, adherence, and cost implications of remotely monitored fall prevention programs.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

This study will evaluate the Fall Prevention Pathways (FPP) program, a digital rehabilitation intervention that assesses the impact of remote monitoring in reducing fall risk in community-dwelling older adults.

Participants will be enrolled in an 8-week intervention and followed for an additional 6 months. The study will assess feasibility, patient adherence, engagement, clinical outcomes, and cost implications. Data collection will occur at baseline (0 weeks), post-intervention (8 weeks), and follow-ups at 13 weeks (3 months) and 26 weeks (6 months).

Tipo de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Madeleine E. Hackney, Ph.D.
  • Número de telefone: 314-412-4852
  • E-mail: mehackn@emory.edu

Locais de estudo

    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30329
        • Recrutamento
        • Executive Park
        • Contato:
          • Madeleine E. Hackney, PhD
          • Número de telefone: 314-412-4852
          • E-mail: mehackn@emory.edu

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

Inclusion Criteria:

  • Adults aged 65-85 years
  • Community-dwelling individuals classified as low to moderate fall risk based on standardized assessments, (i.e., the Stay Independent Screener)
  • Ability to ambulate independently or with a single-point cane
  • Willingness to participate in an 8-week intervention with remote monitoring
  • Access to a smartphone, tablet, or computer with internet connectivity
  • Ability to provide informed consent

Exclusion Criteria:

  • Severe cognitive impairment or a diagnosis of dementia that would affect adherence or ability to provide consent
  • Neurological or vestibular disorders (e.g., Parkinson's disease, multiple sclerosis, history of stroke with residual balance impairment)
  • Severe comorbidities that significantly impact mobility and function (e.g., recent orthopedic surgery, unstable cardiac conditions)
  • Significant visual or hearing impairments that prevent engagement with digital health interventions
  • Non-ambulatory or requiring assistance of another person for mobility

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: The Fall Prevention Pathway (FPP)
Participants will be enrolled in an 8-week FPP intervention program. After completion of the 8-week FPP intervention, participants will undergo long-term follow-up assessments at 13 weeks (3 months) and 26 weeks (6 months) post-intervention. The follow-up assessments aim to assess sustained engagement, adherence, clinical outcomes, and fall incidence.
The Fall Prevention Pathway (FPP) is a digital progression of exercises & patient education delivered through a web platform designed to improve balance, boost confidence, and reduce fall risk. The FPP enrolls participants in a Medbridge Pathway and provides remote monitoring by a clinician who personalizes programs and provides verbal education to help reduce fall risk.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Adherence to program
Prazo: At the end of the intervention (8 weeks)
Adherence will be measured as the number of participants who complete ≥3 days of activity per week
At the end of the intervention (8 weeks)
Number of participants who complete the intervention
Prazo: 3 months and 6 months post-intervention
Number of participants (Retention rate) who remain in the study
3 months and 6 months post-intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
30-Second Sit-to-Stand test
Prazo: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
The number of sit-to-stand maneuvers completed in 30 seconds is used to measure leg strength and endurance. A higher score is better.
Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Gait speed over 20 feet
Prazo: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Gait speed testing (Forward/Backwards/Fast): How quickly a person can walk within a 20-foot distance forward and Backwards using GAITRite. GAITRite is a pressure-sensitive walkway that can assess gait anomalies. Lower scores are better.
Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual)
Prazo: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Measures the time it takes to rise from a chair, walk 3 meters, turn around, and return to the chair in the simple condition. In the Cognitive condition, one is required to simultaneously count backward by 3s from a number between 20 and 100; in the Manual condition, one is required to simultaneously pick up a cup of water and carry it while completing the task. A lower score is a better outcome.
Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Tandem stance (from 4 stage balance test),
Prazo: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

The tandem stance in the 4-Stage Balance Test is a static balance position where the participant stands with one foot directly in front of the other, with the heel of the front foot touching the toes of the back foot. It assesses static balance and postural stability by significantly narrowing your base of support. Screens for fall risk, specifically in older adults.

Scoring: Time tracked: Measured using a stopwatch up to 10 seconds with eyes open. Pass criteria: Must maintain the heel-to-toe position for 10 full seconds without moving the feet or grabbing support/the tester.

Stop condition: The test stops immediately if the person cannot reach the 10-second mark, meaning their final score is recorded at the highest stage successfully completed.

Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Short Form 12-Quality of Life (SF12)
Prazo: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

The SF12 evaluates the level of activity and perceived physical and mental quality of life.

The SF-12 uses a standardized system with scores ranging from 0 to 100, where the general population's average is 50, with higher scores indicating better health. Because it measures relative deviation, the numbers represent the following health levels:

Above 50: Better than average health. Exactly 50: Average health status. 40 to 50: Below average health (mild disability or impairment). 30 to 40: Moderate disability or impairment. Below 40: Severe impairment or disability.

Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Falls Efficacy Scale (FES-I)
Prazo: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

The Falls Efficacy Scale-International (FES-I) measures a person's level of concern or fear about falling while performing 16 everyday indoor and outdoor activities. Each activity is rated on a 4-point Likert scale from 1 to 4; with 1 = Not at all concerned; 2 = Somewhat concerned; 3 = Fairly concerned and 4 = Very concerned. All 16 item scores are added together for the final sum.

Minimum Score: 16 (indicates no concern about falling) Maximum Score: 64 (indicates severe or extreme concern about falling)

Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Activities-specific Balance Confidence Scale (ABC)
Prazo: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)

The Activities-specific Balance Confidence (ABC) Scale is a 16-item self-report questionnaire used to measure an individual's confidence in performing daily activities without losing their balance or feeling unsteady. Participants rate their self-confidence on a percentage scale from 0% (no confidence) to 100% (completely confident) for 16 specific tasks.

The total score is added for all 16 items and divided by 16 to get the average percentage score.

≥ 80%: Indicates a high level of physical functioning and balance confidence. 50% to 80%: Indicates a moderate level of physical functioning. < 50%: Indicates a low level of physical functioning.

Higher scores indicate a higher level of functioning and a lower risk of falling, while lower scores (below 67%) often indicate a higher risk of falling.

Score Interpretation:

16-19: Low concern about falling 20-27: Moderate concern about falling 28-64: High concern about falling

Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Physical Activity Scale for the Elderly (PASE)
Prazo: Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
The PASE score combines information on leisure, household, and occupational activity. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.
Baseline, 8 weeks (end of intervention), 3 months and 6 months (post-intervention)
Net Promoter Score (NPS)
Prazo: 8 weeks (end of the intervention)

The Net Promoter Score (NPS) will be used to measure the participants' satisfaction. A Net Promoter Score (NPS) is a customer loyalty and satisfaction metric that measures how likely a person is to recommend a company, product, or service to a friend or colleague. Businesses ask one simple survey question: "On a scale of 0 to 10, how likely are you to recommend us?"

Promoters (Score 9-10): Loyal and enthusiastic fans who will keep buying and tell others.

Passives (Score 7-8): Satisfied customers who are unenthusiastic and vulnerable to competitors.

Detractors (Score 0-6): Unhappy customers who can damage your brand through negative word-of-mouth

8 weeks (end of the intervention)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Madeleine E. Hackney, Ph.D., Emory University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de setembro de 2025

Conclusão Primária (Estimado)

1 de setembro de 2028

Conclusão do estudo (Estimado)

1 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

11 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de setembro de 2026

Primeira postagem (Real)

17 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2025P011033

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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