- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04589988
Altern mit langfristigen körperlichen Behinderungen
Aufbau von Kapazitäten zur Verbesserung der gesellschaftlichen Teilhabe für Menschen, die mit Langzeitbehinderung altern, durch evidenzbasierte Strategien
The purpose of this study is to determine the feasibility and efficacy of an adapted evidence-based program (REBIL) to reduce barriers to community participation and remove fall hazards at home for adults aging with physical disabilities.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Investigators will test the working hypothesis that the adapted program, focused on resolving environmental barriers, removing fall hazards, and building self-management skills in the home and community, will be feasible and superior to usual care for daily activity performance and participation outcomes in adults aging with physical disabilities.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63108
- Washington University School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Age 45-65 years
- Self-report of difficulty with at least 2 daily activities using the Older Adult Retirement Survey Activities of Daily Living (OARS ADL) scale
- onset of a physical disability 5 years prior to participation (e.g., spinal cord injury (SCI), cerebral palsy, post-polio syndrome, stroke, amputation).
- live within 60 miles of the research lab
Exclusion Criteria:
- Currently institutionalized.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: REBIL- Intervention arm
Participants in this arm will receive the Removing Environmental Barriers to Independent Living (REBIL) intervention. |
REBIL is a complex intervention with two essential components: (1) removing environmental barriers and home hazards in the home tailored to the participant's unique abilities and limitations and (2) strategy training with the participant to help participant to be able to identify barriers in the home and community and identify potential resources and strategies to remove the barriers. Treatment includes one assessment session and four 75-minute visits in the home with an occupational therapist over 8 weeks, followed by a 6 -month assessment session by a blinded rater. |
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Sonstiges: Waitlist Attentional control
Participants in this arm will receive life interview visits provided by a trained occupational therapist (OT) or OT student remotely for an equivalent amount of time to the treatment group. The waitlist control group will be offered the REBIL intervention after the 6-month follow-up is completed. |
The waitlist attentional control group will receive an initial assessment session then four 75 minute interview visits from an occupational therapy graduate assistant, followed by a 6-month assessment session by a blinded rater. After the 6-month follow-up is completed this group will receive the REBIL intervention. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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In-Home Occupational Performance Evaluation (I-HOPE) Activity Score
Zeitfenster: Baseline and 6-month follow up
|
The In-Home Occupational Performance Evaluation (I-HOPE) activity score measures current activity patterns of participants across 44 activities. The score ranges from 0 to 1.0, with a higher score indicating fewer problematic activities for the participant. |
Baseline and 6-month follow up
|
|
In-Home Occupational Performance Evaluation (I-HOPE) Performance Score
Zeitfenster: Baseline and 6-month follow up
|
The In-Home Occupational Performance Evaluation (I-HOPE) performance score is a mean rating across up to 10 participant-prioritized activities on a scale of 1 (unable to perform the activity at all) to 5 (able to perform the activity without difficulty). |
Baseline and 6-month follow up
|
|
In-Home Occupational Performance Evaluation (I-HOPE) Satisfaction Score
Zeitfenster: Baseline and 6-month follow up
|
The In-Home Occupational Performance Evaluation (I-HOPE) satisfaction score is a mean rating across up to 10 participant-prioritized activities on a scale of 1 (not satisfied at all with the performance of the activity) to 5 (very satisfied with their performance of the activity). |
Baseline and 6-month follow up
|
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In-Home Occupational Performance Evaluation (I-HOPE) Barrier Severity Score
Zeitfenster: Baseline and 6-month follow up
|
The In-Home Occupational Performance Evaluation (I-HOPE) barrier severity score is a total sum of barrier ratings (0=independent with/without a device, 1=stand-by assistance needed, 2=minimum assistance needed, 3=moderate assistance needed, 4=maximum assistance needed, 5=no activity) for all identified barriers across up to 10 prioritized activities. Multiple barriers could be identified for each prioritized activity. Higher scores indicate greater barrier severity. There is no maximum score. |
Baseline and 6-month follow up
|
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Reintegration to Normal Living Index (RNLI)
Zeitfenster: Baseline and 6-month follow-up
|
The Reintegration to Normal Living Index is a disability-related quality-of life-instrument that will be used to measure participants' satisfaction with their home and community participation and has been validated on a population of community-dwelling individuals with chronic conditions. It uses an 11-item, 10 point visual analog scale with higher scores indicating greater reintegration to normal living. The sum score is divided by 110 and then multiplied by 100 to obtain an adjusted score. Adjusted scores range from 0 to 100, with higher scores indicating greater reintegration to normal living. |
Baseline and 6-month follow-up
|
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Westmead Home Safety Assessment (WeHSA) Short Form
Zeitfenster: Baseline and 6-month follow up
|
The Westmead Home Safety Assessment (WeHSA) short form is a performance-based assessment of fall hazards in different spaces of the home (e.g., kitchen, bathroom, hallway, bedroom etc.). WeSHA scores indicate the total number of environmental fall hazards in the home. |
Baseline and 6-month follow up
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Fall Prevention Strategy Survey (FPSS)
Zeitfenster: Baseline and 6-month follow-up
|
The Fall Prevention Strategy Survey is a self-report instrument addressing protective behaviors related to fall risk among adults. It is an 11-item survey, scores range from 0 to 22 with higher scores indicating use of more fall prevention strategies. |
Baseline and 6-month follow-up
|
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Participation Scale
Zeitfenster: Baseline and 6-month follow-up
|
This scale comprises 25 diverse activities across four participation domains: routines, recreation, responsibilities, and relationships. Ratings were on a five-point Likert-type scale regarding the frequency of participation, the importance of the activity, and their self-efficacy in completing it. We calculated the ratio of number of important/very important activities they could perform very much/as much as they wanted (numerator) to the number of important/very important activities (denominator). |
Baseline and 6-month follow-up
|
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Fall Rate
Zeitfenster: 6 months
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Participants reported monthly on the number of falls they experienced in the past month. A fall was defined as an unexpected event in which a person comes to rest on the ground, floor, or a lower level. Fall rates were calculated as the number of falls per 1000 observed participant days. |
6 months
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Susan Stark, PhD, Washington University School of Medicine
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 201710186
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
The data (feasibility, primary and secondary outcomes) will be shared via a data repository.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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