Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial.

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dc.contributor.authorIrgens, Ingebjørg
dc.contributor.authorHoff, Jana M
dc.contributor.authorSørli, Hilde
dc.contributor.authorHaugland, Hanne
dc.contributor.authorStanghelle, Johan K
dc.contributor.authorRekand, Tiina
dc.date.accessioned2020-06-08T14:41:13Z
dc.date.available2020-06-08T14:41:13Z
dc.date.issued0000-00-00
dc.description.abstractBACKGROUND Individuals with spinal cord injuries SCI are prone to pressure ulcers PUs because of the loss of sensorimotor function involved as well as increased skin moisture Treatment of PU after SCI is complicated involving different specialties and with need for long lasting follow up This study should identify risk factors for PU after SCI and find an effective and less time consuming treatment for the condition among different available methods for follow up METHOD DESIGN The first part of this research project aims to investigate the prevalence of PU among persons with SCI based on an epidemiological design The study will identify possible risk factors for acquiring PU A questionnaire focusing on previous and present PUs will be sent to persons who suffered SCIs between January 2004 and January 2014 In the second part we will compare two different treatment regimens of PU through a randomized controlled pilot trial RCT where we will compare outpatient SCI follow up in a hospital versus outpatient follow up from the patient s home using telemedicine teleSCI interventions We will compare the healing of the PU in the two groups usual care versus teleSCI The Tissue Infection Moisture Edge TIME registration form the Photographic Wound Assessment Tool PWAT and the change in the ulcer size will be used to monitor the healing Changes in health related quality of life HRQoL and the need for assistance will be assessed using the Five Dimensions European Quality of Life scale EQ 5D the generic Medical Outcomes Study 12 item Short Form Health Survey SF 12 modified version the International Spinal Cord Injury Quality of Life Data set ISCI QoL Data set and the Spinal Cord Independence Measure scale version III SCIM III In addition to primary outcome measures a cost benefit evaluation and an assessment of patient satisfaction and participation will be performed using customized questionnaires DISCUSSION The first part of the research project will reveal the epidemiology of PU after SCI and explore the risk factors This part enables further prevention of PU after SCI and this information will be used in the follow up RCT Videoconferencing in the outpatient follow up of persons with SCI and PU will change clinical routines and facilitate interdisciplinary collaboration communication and competence exchange among participants of the health care services Our research protocol allows comparing methods for interaction between medical specialists at hospitals local caregivers in the community next of kin and persons with SCI and PU The RCT should identify advantages as well as challenges in the management of PU in different follow up settings This study aims to identify risk factors for PU after SCI and find an effective and less time consuming treatment for the condition among different available methods for follow up TRIAL REGISTRATION 1 www ClinicalTrials gov ID NCT02800915 last update 9 October 2017 2 The National Regional Ethical Committee REC 2014 684 REK Nord https helseforskning etikkom no prosjekterirek prosjektregister prosjekt p document id 469163Andp parent id 473640And ikbLanguageCode n 3 https app cristin no projects show jsf id 545284 4 https www sunnaas no kliniske studier bruk av telemedisin som virkemiddel til samhandling i poliklinisk oppfolging av pasienter med ryggmargsskade og trykksar
dc.identifier.urihttp://dx.doi.org/10.1186/s13063-019-3185-y
dc.identifier.urihttps://lib.digitalsquare.io/handle/123456789/65015
dc.relation.uriTrials
dc.titleHospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial.en
dcterms.abstractBACKGROUND Individuals with spinal cord injuries SCI are prone to pressure ulcers PUs because of the loss of sensorimotor function involved as well as increased skin moisture Treatment of PU after SCI is complicated involving different specialties and with need for long lasting follow up This study should identify risk factors for PU after SCI and find an effective and less time consuming treatment for the condition among different available methods for follow up METHOD DESIGN The first part of this research project aims to investigate the prevalence of PU among persons with SCI based on an epidemiological design The study will identify possible risk factors for acquiring PU A questionnaire focusing on previous and present PUs will be sent to persons who suffered SCIs between January 2004 and January 2014 In the second part we will compare two different treatment regimens of PU through a randomized controlled pilot trial RCT where we will compare outpatient SCI follow up in a hospital versus outpatient follow up from the patient s home using telemedicine teleSCI interventions We will compare the healing of the PU in the two groups usual care versus teleSCI The Tissue Infection Moisture Edge TIME registration form the Photographic Wound Assessment Tool PWAT and the change in the ulcer size will be used to monitor the healing Changes in health related quality of life HRQoL and the need for assistance will be assessed using the Five Dimensions European Quality of Life scale EQ 5D the generic Medical Outcomes Study 12 item Short Form Health Survey SF 12 modified version the International Spinal Cord Injury Quality of Life Data set ISCI QoL Data set and the Spinal Cord Independence Measure scale version III SCIM III In addition to primary outcome measures a cost benefit evaluation and an assessment of patient satisfaction and participation will be performed using customized questionnaires DISCUSSION The first part of the research project will reveal the epidemiology of PU after SCI and explore the risk factors This part enables further prevention of PU after SCI and this information will be used in the follow up RCT Videoconferencing in the outpatient follow up of persons with SCI and PU will change clinical routines and facilitate interdisciplinary collaboration communication and competence exchange among participants of the health care services Our research protocol allows comparing methods for interaction between medical specialists at hospitals local caregivers in the community next of kin and persons with SCI and PU The RCT should identify advantages as well as challenges in the management of PU in different follow up settings This study aims to identify risk factors for PU after SCI and find an effective and less time consuming treatment for the condition among different available methods for follow up TRIAL REGISTRATION 1 www ClinicalTrials gov ID NCT02800915 last update 9 October 2017 2 The National Regional Ethical Committee REC 2014 684 REK Nord https helseforskning etikkom no prosjekterirek prosjektregister prosjekt p document id 469163Andp parent id 473640And ikbLanguageCode n 3 https app cristin no projects show jsf id 545284 4 https www sunnaas no kliniske studier bruk av telemedisin som virkemiddel til samhandling i poliklinisk oppfolging av pasienter med ryggmargsskade og trykksar
dcterms.contributorIrgens, Ingebjørg
dcterms.contributorHoff, Jana M
dcterms.contributorSørli, Hilde
dcterms.contributorHaugland, Hanne
dcterms.contributorStanghelle, Johan K
dcterms.contributorRekand, Tiina
dcterms.identifierhttp://dx.doi.org/10.1186/s13063-019-3185-y
dcterms.relationTrials
dcterms.titleHospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial.en
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