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Fall Prevention Pathways

2026年9月11日 更新者: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.

調査の概要

状態

募集

条件

詳細な説明

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).

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Madeleine E. Hackney, Ph.D.
  • 電話番号:314-412-4852
  • メール:mehackn@emory.edu

研究場所

    • Georgia
      • Atlanta、Georgia、アメリカ、30329
        • 募集
        • Executive Park
        • コンタクト:
          • Madeleine E. Hackney, PhD
          • 電話番号:314-412-4852
          • メール:mehackn@emory.edu

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 高齢者

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Adherence to program
時間枠: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
時間枠:3 months and 6 months post-intervention
Number of participants (Retention rate) who remain in the study
3 months and 6 months post-intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
30-Second Sit-to-Stand test
時間枠: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
時間枠: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)
時間枠: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),
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

協力者

捜査官

  • 主任研究者:Madeleine E. Hackney, Ph.D.、Emory University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年9月29日

一次修了 (推定)

2028年9月1日

研究の完了 (推定)

2028年9月1日

試験登録日

最初に提出

2026年9月11日

QC基準を満たした最初の提出物

2026年9月11日

最初の投稿 (実際)

2026年9月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月17日

QC基準を満たした最後の更新が送信されました

2026年9月11日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2025P011033

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いいえ

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