- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00447655
Improving Outcomes Following Limb Loss: PALS Plus (PALS-PLUS)
12 december 2017 uppdaterad av: Johns Hopkins University
Limb loss can result from a variety of etiologies including diabetes, trauma and cancer.
Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life.
Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and established the effectiveness of a self-management program (PALS) to improve health and outcomes following limb loss.
Literature suggests that the access to, and effectiveness and utilization of, this class of interventions may be enhanced by the concerted use of early intervention, peer mentorship, motivational interviewing and provider training.
Objectives: Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention- PALS Plus.
The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS Plus intervention in maximizing utilization of self-management interventions for persons with limb loss.
A cohort of 200 patients will be enrolled prior to implementation of the intervention and will serve as the control group.
Subsequently, a second cohort of 200 patients will be enrolled and receive the PALS Plus intervention and will serve as the intervention group.
Assessment will be at baseline, treatment completion and six month follow-up.
Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood.
Secondary outcome measures are: function, participation and bothersomeness of limitations.
The investigation will also provide unique and valuable information regarding patients' acceptance and use of peer visitation and self-management following limb loss.
Relevance: By establishing the utility and effectiveness of the enhanced self-management intervention, there is the potential to improve the health, activity, participation and quality of life for individuals with disabilities.
The intervention addresses the areas of activity and participation in such a way that it can be implemented in local health care facilities working in combination with a national consumer based organization - the Amputee Coalition of America.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Limb loss can result from a variety of etiologies including diabetes, trauma and cancer.
Following limb loss, individuals are at elevated risk for activity limitations and participation restrictions with significant impact on health and quality of life.
Intervention: Working with the Amputee Coalition of America we have developed, evaluated, and established the effectiveness of a self-management program (PALS) to improve health and outcomes following limb loss.
Literature suggests that the access to, and effectiveness and utilization of, this class of interventions may be enhanced by the concerted use of early intervention, peer mentorship, motivational interviewing and provider training.
Objectives: Our goal is to evaluate the effectiveness of an enhanced, early self-management intervention- PALS Plus.
The specific aims are:1) evaluate the effectiveness of the PALS Plus intervention in improving outcomes for persons with limb loss; (2) evaluate the effectiveness of the PALS Plus intervention in maximizing utilization of self-management interventions for persons with limb loss.
Study Design and Participants: The prospective clinical trial will use a two group, lagged-control design to evaluate the intervention at five health care facilities.
A cohort of 200 patients will be enrolled prior to implementation of the intervention and will serve as the control group.
Subsequently, a second cohort of 200 patients will be enrolled and receive the PALS Plus intervention and will serve as the intervention group.
Assessment will be at baseline, treatment completion and six month follow-up.
Outcomes: Primary outcome measures are: pain, depressed mood, and positive mood.
Secondary outcome measures are: function, participation and bothersomeness of limitations.
Improvements in primary and secondary outcomes will result through the impact on self efficacy, patient activation, catastrophizing and social support.
The investigation will also provide unique and valuable information regarding patients' acceptance and use of peer visitation and self-management following limb loss.
Relevance: By establishing the utility and effectiveness of the enhanced self-management intervention, there is the potential to improve the health, activity, participation and quality of life for individuals with disabilities.
The intervention addresses the areas of activity and participation in such a way that it can be implemented in local health care facilities working in combination with a national consumer based organization - the Amputee Coalition of America.
Studietyp
Interventionell
Inskrivning (Faktisk)
400
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21239
- Good Samaritan Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Adults (aged 18-85 years) of both sexes and all races admitted to one of the seven participating acute care hospitals or rehabilitation facilities for an amputation procedure and/or treatment immediately following an amputation procedure, including traumatic amputations as well as amputations due to complications for diabetes mellitus, peripheral vascular disease, and malignancy.
- Women and minority patients will be represented in the trial according to the gender and race/ethnic prevalence of patients receiving treatment at the designated hospital and rehabilitation centers.
Exclusion Criteria:
Criteria for exclusion from the study will include:
- Age less than 18 or over 85 years; and
- Inability to communicate in written or spoken English.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
---|
Primary outcome measures are: pain, depressed mood, and positive mood.
|
Sekundära resultatmått
Resultatmått |
---|
Secondary outcome measures are: function, participation and bothersomeness of limitations
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Stephen T Wegener, PHD, Johns Hopkins University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2007
Primärt slutförande (Faktisk)
1 augusti 2009
Avslutad studie (Faktisk)
1 augusti 2009
Studieregistreringsdatum
Först inskickad
14 mars 2007
Först inskickad som uppfyllde QC-kriterierna
14 mars 2007
Första postat (Uppskatta)
15 mars 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 december 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 december 2017
Senast verifierad
1 december 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CDC R01DD000153
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Amputation
-
Liberating Technologies, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development... och andra samarbetspartnersAvslutadAmputation | Protesanvändare | Amputation; Traumatisk, Hand | Amputation, medföddFörenta staterna
-
Shirley Ryan AbilityLabEunice Kennedy Shriver National Institute of Child Health and Human Development...Aktiv, inte rekryterandeAmputation | Amputation; Traumatisk, lem | Amputation av övre extremiteter vid handen | Amputation av övre extremiteterna vid handledenFörenta staterna
-
Medipol UniversityRekryteringAmputation | Amputation; Traumatisk, Ben, NedreKalkon
-
Boninger, Michael, MDNational Institute of Neurological Disorders and Stroke (NINDS); Ripple...RekryteringAmputation | Amputation; Traumatisk, HandFörenta staterna
-
Fondazione Don Carlo Gnocchi OnlusAvslutadAmputation | Amputation; Traumatisk, Ben, NedreItalien
-
Fondazione Don Carlo Gnocchi OnlusAvslutadAmputation | Amputation; Traumatisk, Ben, NedreItalien
-
Hacettepe UniversityAvslutad
-
University of MichiganAktiv, inte rekryterandeAmputation | Amputation; Traumatisk, Ben, NedreFörenta staterna
-
Shirley Ryan AbilityLabUnited States Department of DefenseAvslutadAmputation | Amputation; Traumatisk, Arm, ÖvreFörenta staterna
-
Coapt, LLCCongressionally Directed Medical Research ProgramsAvslutadProtesanvändare | Medfödd amputation av övre extremiteterna | Amputation; Traumatisk, lemFörenta staterna
Kliniska prövningar på Self-management and peer support
-
University of MichiganRekrytering
-
University of MichiganNational Institutes of Health (NIH); National Institute on Aging (NIA); Blue...Avslutad
-
University of MichiganNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Avslutad
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Rekrytering
-
Omada Health, Inc.Palo Alto Medical Foundation; Sutter HealthAvslutadDiabetes typ 2Förenta staterna
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)AvslutadHjärtsvikt, kongestivFörenta staterna
-
NYU Langone HealthAgency for Healthcare Research and Quality (AHRQ)Har inte rekryterat ännuDiabetes typ 2Förenta staterna
-
University of MichiganNational Institute on Aging (NIA)Har inte rekryterat ännuKronisk smärta | Kognitiv försämring
-
University of ArizonaRekrytering
-
University College London HospitalsAvslutadNeuromuskulära sjukdomarStorbritannien