KEEP Intervention for People Newly Diagnosed With Parkinson's (KEEP)
1 de noviembre de 2022 actualizado por: Ledia Alushi, University of Cambridge
KEEP- A Randomised Feasibility Study of a Co-designed Physical Health Education Intervention to Improve Knowledge, Exercise Efficacy and Participation for Newly Diagnosed People With Parkinson's.
Parkinson's Disease (PD) is a progressive neurological condition that affects movement, balance and cognition, resulting in loss of independence and compromised quality of life over the course of the condition. Research suggests that those detrimental outcomes can be reduced through physical activity (PA) and exercise, especially when those are started early. Educating people with Parkinson's (PwP) on the role of PA and exercise in PD progression can boost PA engagement by increasing enablers such as exercise self-efficacy and removing barriers such as misinformation about exercise and exercise outcomes.
Working closely with PwP and healthcare professionals, a physical health education programme was co-designed to address the needs and preferences of PwP around exercise and PA education. The process was supervised by the patient and Public Involvement group attended by PwP, academics, researchers and clinicians working with PwP.
The study will utilise an assessor blinded randomised controlled design to investigate the acceptability and feasibility of delivering an online physical health education programme for PwP who are newly diagnosed. Thirty PwP, diagnosed in the last 12-months, will be randomly allocated into two groups: 1) the intervention group in which participants will receive online education modules and will be invited to attend virtual group sessions with a specialist neuro-physiotherapist; 2) the control group which will follow the usual care pathway and participants will receive Parkinson's UK booklets.
The aim of the study is to explore an alternative approach to standard care regarding patient education in PD and evaluate the feasibility and acceptability of a co-designed education intervention for newly diagnosed PwP delivered online. Feasibility data will be collected during the study and acceptability data will be assessed via a questionnaire at the end. Outcomes including PA levels, exercise knowledge, exercise efficacy, and participation will be assessed at baseline, post-intervention and at 6 months.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Cambridge, Reino Unido, CB2 0SZ
- Department of Psychiatry
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Clinical diagnosis of Idiopathic Parkinson's Disease
- Within 12 months since diagnosis
- Stable medication regime for four weeks prior to initiation of trial
- Ability to understand written English
Exclusion Criteria:
- Acute illness
- History of neurological disorder other than Parkinson Disease
- Diagnosis of dementia or significant cognitive impairments
- Participation in NHS structured PD-specific education program with or without exercise classes in the last year
- Unable to understand written English
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intervention group
The experimental group will receive: Online education modules Online group discussions facilitated by Specialist Physiotherapist |
Educational intervention
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Comparador activo: Control Group
The comparator for this study is usual care pathway.
Under the usual care pathway, participants will receive education booklets on exercise by Parkinson's UK.
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booklet from Parkinson's UK
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability assessment 1: Recruitment rate
Periodo de tiempo: Through study completion (12 months)
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Assessment of recruitment rate of study (% of eligible participants enrolled)
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Through study completion (12 months)
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Acceptability assessment 2: Education programme compliance
Periodo de tiempo: Through study completion (12 months)
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Compliance with the online education programme (% of sessions completed)
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Through study completion (12 months)
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Acceptability assessment 3: Drop out rate
Periodo de tiempo: Through study completion (12 months)
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Comparison of drop out rates (%) between the intervention group and control group
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Through study completion (12 months)
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Acceptability assessment 4: Acceptability of Intervention
Periodo de tiempo: Completed at the end of participation in the study (after 8 weeks)
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A questionnaire designed to assess satisfaction with the education intervention.
it includes multiple choice and open ended questions.
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Completed at the end of participation in the study (after 8 weeks)
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Feasibility of delivering the intervention online
Periodo de tiempo: Through study completion (12 months)
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Assessment of any technical problems or difficulties accessing online intervention as reported by participants
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Through study completion (12 months)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Unified Parkinson's Disease Rating Scale Part 3
Periodo de tiempo: Baseline(week 0) and follow up (6-month post intervention)
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The UPDRS is the gold-standard scale for Parkinson's assessment and has four parts.
For this study only UPDRS III, motor examination will be completed by a trained assessor.
UPDRS III total scores range from 7 to 86 points, with higher scores indicating more severe impairment..
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Baseline(week 0) and follow up (6-month post intervention)
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MiniBESTest
Periodo de tiempo: Baseline(week 0) and follow up (6-month post intervention)
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The Mini-BEST is a 14-item scale that assesses dynamic balance components including anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait.
The data is based on a total score of 28 points, with higher score indicating better task performance.
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Baseline(week 0) and follow up (6-month post intervention)
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Five time Sit To Stand
Periodo de tiempo: Baseline(week 0) and follow up (6-month post intervention)
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Five time sit to stand is a validated test used to assess functional lower extremity strength, balance and risk falls in older adults.
It has been used in PD population with high interrater and test-retest reliability.
Longer time to complete indicates worse task performance.
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Baseline(week 0) and follow up (6-month post intervention)
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Self-efficacy for Exercise
Periodo de tiempo: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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The Self-Efficacy for exercise (SEE) scale is a 9-item validated scale which assesses a person self-efficacy to exercise under different circumstances.
This scale is a modified version of Bandura's Exercise Self-Efficacy Scale and ask participants to rate their perceived exercise efficacy on a scale form 0 meaning not confident at all to 10 meaning very confident.
Higher score indicate higher self-efficacy
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Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Hospital Anxiety and Depression Scale
Periodo de tiempo: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Hospital Anxiety and Depression Scale (HADS) is a widely used questionnaire to measure anxiety and depression.
A self-reported brief instrument which includes 14 questions aiming to detect and indicate severity of anxiety and depression.
It has been used before and is a validated and reliable tool to use in Parkinson's population.
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Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Apathy Evaluation Scale
Periodo de tiempo: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Apathy Evaluation Scale (AES) is a standardised and validated self-rating instrument to evaluate apathy.
It consists of 18 items that are scored on a 4-point Likert Scale, with highest score indicating more severe apathy
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Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Multidimensional Outcome Expectation Scale
Periodo de tiempo: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Outcome expectations about the benefits of regular exercise and PA will be measured by the Multidimensional Outcomes Expectations for Exercise Scale (MOEES).
The MOEES has 15 items that reflect three subdomains of outcome expectations.
The items were rated on a five-point scale from 1 (Strongly disagree) to 5 (Strongly agree) and summed to form the subscale measures of outcome expectations with higher scores reflecting greater beliefs about the benefits of regular exercise and physical activity.
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Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Oxford Participation and Activities Questionnaire
Periodo de tiempo: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Oxford Participation and Activities Questionnaire (Ox-PAQ) is a patient-reported outcome measure comprised of 23 items aiming to assess participation and activity in patients with long-term conditions.
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Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Recent Physical Activity Questionnaire
Periodo de tiempo: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Physical Activity will be measured subjectively and objectively.
Subjectively it will be measured via the self-reported Recent Physical Activity Questionnaire (RPAQ), which is designed to assess PA in everyday life in the last 4 weeks.
The questionnaire has three sections assessing a range of activities in different domains (around the house, work and recreation).
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Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Knowledge of Exercise and Physical Activity
Periodo de tiempo: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Knowledge of Exercise and Physical Activity questionnaire is a 10-item knowledge questionnaire around the role of exercise and physical activity in the management of PD and it has been designed by the PI to assess knowledge levels.
A total score of 10 indicates better knowledge scores.
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Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Wrist-worn accelerometer
Periodo de tiempo: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Objectively, physical activity will be measured with the use of a wrist-worn accelerometer (GeneActiv monitor) over 7 consecutive days.
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Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
18 de junio de 2022
Finalización primaria (Actual)
21 de septiembre de 2022
Finalización del estudio (Anticipado)
18 de junio de 2023
Fechas de registro del estudio
Enviado por primera vez
2 de febrero de 2022
Primero enviado que cumplió con los criterios de control de calidad
11 de febrero de 2022
Publicado por primera vez (Actual)
23 de febrero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de noviembre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
1 de noviembre de 2022
Última verificación
1 de noviembre de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A096150
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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