Late effects of a brief psychological intervention in patients with intermittent claudication in a randomized clinical trial

Cunningham, Myles P.; Swanson, Vivien; Holdsworth, R. J.; O’Carroll, Ronan E.

doi:10.1002/bjs.9100

Cited by 27 publications

(63 citation statements)

References 18 publications

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“…Components of successful interventions to promote unsupervised exercise in people with IC include self-monitoring, goal setting, and problem solving barriers [96]. Behavioral counselling typically includes these components, and there is preliminary evidence that brief behavioral counselling by a psychologist can promote sustained increases in walking in people with PAD [53, 54], but the generalisability of this to other health professionals is not known. In addition, little is known about the impact of such programs on cardiovascular disease risk [96].…”

Section: Discussionmentioning

confidence: 99%

“…We also hypothesise that these effects will be maintained at 12 and 24 months post intervention. The effect size and outcome results estimated are based on data from a previous trial [54]. We require 62 participants per group (power 90 %, alpha 0.05, within-subject between visit correlation 0.6) to detect the hypothesised increase in physical activity.…”

Section: Methodsmentioning

confidence: 99%

“…A more brief counselling intervention, involving two 1-h sessions of individualised behavioral counselling and two follow up telephone calls by a psychologist, demonstrated a significant increase in pain-free walking distance and daily walking in the intervention versus the control group (usual care plus non-walking related conversation during home visits) after four months, with a mean difference of 1575 pedometer steps/day (95 % CI, 732 to 2419) [53]. At 24 months, the intervention group completed on average 1630 steps/day (95 % CI, 495 to 2765) more than the control group, and significantly more participants in the control group had endovascular or open surgery than in the intervention group (OR 3.09 95 % CI 1.06 to 9.04; p = 0.037) [54]. However, as the counselling was delivered by a psychologist in patients’ homes, the wide scale applicability of this approach is not known.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial

et al. 2016

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BackgroundPhysical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD.MethodsThis is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation. Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost-effectiveness analysis will estimate change in cost per change in activity indicators due to the intervention, and a cost-utility analysis will assess change in cost per quality-adjusted life year. A full uncertainty analysis will be undertaken, including a value of information analysis, to evaluate the economic case for further research.DiscussionThis trial will evaluate the efficacy and cost-effectiveness of a brief behavioral counselling intervention for a common cardiovascular disease with significant burden.Trial registrationACTRN 12614000592640 Australian New Zealand Clinical Trials Registry. Registration Date 4 June 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s12889-016-3801-7) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial

et al. 2016

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“…Existen estudios centrados en el ejercicio domiciliario supervisado. Esta supervisión la realizan mediante cuestionarios 14 o podómetros 15,16 . No obstante, consideramos que la escasa validez de los cuestionarios 14 y los escasos datos que son capaces de recoger los podómetros los convierten en herramientas limitadas.…”

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Aplicabilidad de las nuevas tecnologías a pacientes claudicantes. CReTe: Claudicantes y registro telemático

et al. 2015

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ResumenObjetivo: Presentamos una aplicación informática para teléfonos móviles ideada para el control de sesiones de ejercicio domiciliario en claudicantes. Exponemos también nuestros resultados preliminares. Material y métodos:La aplicación está diseñada para teléfonos móviles con sistema operativo Android, tecnología de geolocalización y conexión de datos. Está conectada a una base de datos codificada que preserva el secreto médico. Los datos que se recogen de las sesiones de ejercicio son la fecha, la hora de inicio y de fin, el tiempo dedicado, el número de las paradas realizadas y la velocidad máxima, la velocidad media global y la velocidad entre paradas. Durante el mes de enero de 2014 se reclutó a aquellos pacientes que aceptaran el estudio, poseyeran y entendieran un dispositivo móvil Android con geolocalización y conexión de datos. Los criterios de exclusión del estudio una vez comenzado fueron progresión hacia isquemia arterial crítica, enfermedad intercurrente grave, fallecimiento y ausencia de comunicación con el paciente. Se recogieron las principales morbilidades y los resultados de los cuestionarios de calidad de vida SF36 y EuroQol 5D. Se midió el tiempo de primera consulta y el tiempo dedicado por semana y paciente durante un seguimiento de 28 días. Se calculó el cumplimiento de las sesiones con respecto a las sesiones pactadas con cada paciente, con un mínimo de 2 semanales. Resultados: Un total de 5 pacientes fueron incluidos, con edad media de 59,3 años (mediana 52; rango 40-80). De ellos 2 se excluyeron, uno por progresión a isquemia crítica y otro por ausencia de comunicación. El tiempo medio dedicado por consulta nueva fue de 29,1 min (mediana 27,5; rango 45-20). El cumplimiento de las sesiones fue del 100% en 2 pacientes y del 63% en otro. El tiempo dedicado en el seguimiento semanal por paciente fue de 1,68 min.Conclusiones: CReTe es una herramienta aplicable a nuestro medio que precisa de estudios mayores para demostrar su utilidad.

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“…Hence, endpoints such as quality of life (QoL) and other perceived health measures (pain, fatigue, and etc.) are increasingly used as important health outcomes in clinical trials and epidemiological studies, and are considered highly valued endpoints of medical care in different areas, for example, rheumatology, oncology, cardiology, and surgery . These types of endpoints are usually referred to as latent variables or latent traits.…”

Section: Introductionmentioning

confidence: 99%

Power and sample size determination for group comparison of patient‐reported outcomes using polytomous Rasch models

Hardouin

Blanchin

Feddag

et al. 2015

Statistics in Medicine

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The analysis of patient-reported outcomes or other psychological traits can be realized using the Rasch measurement model. When the objective of a study is to compare groups of individuals, it is important, before the study, to define a sample size such that the group comparison test will attain a given power. The Raschpower procedure (RP) allows doing so with dichotomous items. The RP is extended to polytomous items. Several computational issues were identified, and adaptations have been proposed. The performance of this new version of RP is assessed using simulations. This adaptation of RP allows obtaining a good estimate of the expected power of a test to compare groups of patients in a large number of practical situations. A Stata module, as well as its implementation online, is proposed to perform the RP. Two versions of the RP for polytomous items are proposed (deterministic and stochastic versions). These two versions produce similar results in all of the tested cases. We recommend the use of the deterministic version, when the measure is obtained using small questionnaires or items with a few number of response categories, and the stochastic version elsewhere, so as to optimize computing time.

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Late effects of a brief psychological intervention in patients with intermittent claudication in a randomized clinical trial

Abstract: ISRCTN28051878 (http://www.controlled-trials.com).

Cited by 27 publications

References 18 publications

Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial

Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial

Aplicabilidad de las nuevas tecnologías a pacientes claudicantes. CReTe: Claudicantes y registro telemático

Power and sample size determination for group comparison of patient‐reported outcomes using polytomous Rasch models

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