KEEP Intervention for People Newly Diagnosed With Parkinson's (KEEP)
1 november 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
30
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Cambridge, Verenigd Koninkrijk, CB2 0SZ
- Department of Psychiatry
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Intervention group
The experimental group will receive: Online education modules Online group discussions facilitated by Specialist Physiotherapist |
Educational intervention
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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Acceptability assessment 1: Recruitment rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Unified Parkinson's Disease Rating Scale Part 3
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
18 juni 2022
Primaire voltooiing (Werkelijk)
21 september 2022
Studie voltooiing (Verwacht)
18 juni 2023
Studieregistratiedata
Eerst ingediend
2 februari 2022
Eerst ingediend dat voldeed aan de QC-criteria
11 februari 2022
Eerst geplaatst (Werkelijk)
23 februari 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 november 2022
Laatste update ingediend die voldeed aan QC-criteria
1 november 2022
Laatst geverifieerd
1 november 2022
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- A096150
Plan Individuele Deelnemersgegevens (IPD)
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ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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