Trials · 2015
A home-based rehabilitation intervention for people living with HIV and disability in a resource-poor community, KwaZulu-Natal: study protocol for a randomised controlled trial.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Cobbing Saul, Hanass-Hancock Jill, Myezwa Hellen
Аннотация
BACKGROUND: In the era of highly active antiretroviral therapy HIV is now viewed as a chronic disease. Although people living with HIV are living longer lives, they are prone to a number of disabilities. Home-based rehabilitation has been shown to be an effective means of improving quality of life and function for people with a wide range of chronic diseases. There is a dearth of evidence, however, related to home-based rehabilitation interventions for people living with HIV, particularly in sub-Saharan Africa - the region with the highest global prevalence of HIV.
METHODS: A randomised controlled trial design will be employed. Adults living with HIV who have been on antiretroviral therapy for at least six months and with defined limited mobility will be randomly allocated to either an intervention group or the control group. Pre and post-intervention testing will be conducted at a public hospital in KwaZulu-Natal, South Africa in order to assess the participants' quality of life, perceived level of disability, functional ability and endurance. Individuals randomly allocated to the intervention group will participate in a four-month home-based rehabilitation programme, conducted once a week in their homes. This programme will be implemented by community workers who will be trained and supervised by a qualified physiotherapist. The participants in the control group will continue with the standard clinic management offered to them. On completion of the intervention, all participants will be re-assessed using the same outcome measures. Analysis of results will be carried out on intention-to-treat basis in order to identify any changes between intervention and control groups.
DISCUSSION: The researchers aim to employ a novel task shifting approach to implement a needs-based home-based rehabilitation programme for people living with HIV in order to improve their quality of life and functional ability. It is hoped that this study will provide rehabilitation professionals and researchers with evidence that can be utilised to improve existing rehabilitation interventions for people living with HIV.
TRIAL REGISTRATION: South African National Clinical Trials Register: NHREC#4094 (Date of registration: 21 July 2015).
METHODS: A randomised controlled trial design will be employed. Adults living with HIV who have been on antiretroviral therapy for at least six months and with defined limited mobility will be randomly allocated to either an intervention group or the control group. Pre and post-intervention testing will be conducted at a public hospital in KwaZulu-Natal, South Africa in order to assess the participants' quality of life, perceived level of disability, functional ability and endurance. Individuals randomly allocated to the intervention group will participate in a four-month home-based rehabilitation programme, conducted once a week in their homes. This programme will be implemented by community workers who will be trained and supervised by a qualified physiotherapist. The participants in the control group will continue with the standard clinic management offered to them. On completion of the intervention, all participants will be re-assessed using the same outcome measures. Analysis of results will be carried out on intention-to-treat basis in order to identify any changes between intervention and control groups.
DISCUSSION: The researchers aim to employ a novel task shifting approach to implement a needs-based home-based rehabilitation programme for people living with HIV in order to improve their quality of life and functional ability. It is hoped that this study will provide rehabilitation professionals and researchers with evidence that can be utilised to improve existing rehabilitation interventions for people living with HIV.
TRIAL REGISTRATION: South African National Clinical Trials Register: NHREC#4094 (Date of registration: 21 July 2015).
Предметные рубрики MeSH
Anti-HIV AgentsAntiretroviral Therapy, Highly ActiveClinical ProtocolsCommunity Health ServicesCost-Benefit AnalysisDeveloping CountriesDisability EvaluationFemaleHIV InfectionsHealth Care CostsHealth StatusHome Care ServicesHumansMaleMobility LimitationPhysical EnduranceQuality of LifeResearch DesignSouth AfricaTime FactorsTreatment Outcome