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KEEP Intervention for People Newly Diagnosed With Parkinson's (KEEP)

1. november 2022 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention group

The experimental group will receive:

Online education modules Online group discussions facilitated by Specialist Physiotherapist
Andet: KEEP Intervention
Educational intervention
Aktiv komparator: 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.
Andet: control
booklet from Parkinson's UK

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptability assessment 1: Recruitment rate
Tidsramme: Through study completion (12 months)
Assessment of recruitment rate of study (% of eligible participants enrolled)
Through study completion (12 months)
Acceptability assessment 2: Education programme compliance
Tidsramme: Through study completion (12 months)
Compliance with the online education programme (% of sessions completed)
Through study completion (12 months)
Acceptability assessment 3: Drop out rate
Tidsramme: Through study completion (12 months)
Comparison of drop out rates (%) between the intervention group and control group
Through study completion (12 months)
Acceptability assessment 4: Acceptability of Intervention
Tidsramme: Completed at the end of participation in the study (after 8 weeks)
A questionnaire designed to assess satisfaction with the education intervention. it includes multiple choice and open ended questions.
Completed at the end of participation in the study (after 8 weeks)
Feasibility of delivering the intervention online
Tidsramme: Through study completion (12 months)
Assessment of any technical problems or difficulties accessing online intervention as reported by participants
Through study completion (12 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Unified Parkinson's Disease Rating Scale Part 3
Tidsramme: Baseline(week 0) and follow up (6-month post intervention)
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..
Baseline(week 0) and follow up (6-month post intervention)
MiniBESTest
Tidsramme: Baseline(week 0) and follow up (6-month post intervention)
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.
Baseline(week 0) and follow up (6-month post intervention)
Five time Sit To Stand
Tidsramme: Baseline(week 0) and follow up (6-month post intervention)
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.
Baseline(week 0) and follow up (6-month post intervention)
Self-efficacy for Exercise
Tidsramme: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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
Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Hospital Anxiety and Depression Scale
Tidsramme: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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.
Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Apathy Evaluation Scale
Tidsramme: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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
Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Multidimensional Outcome Expectation Scale
Tidsramme: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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.
Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Oxford Participation and Activities Questionnaire
Tidsramme: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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.
Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Recent Physical Activity Questionnaire
Tidsramme: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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).
Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Knowledge of Exercise and Physical Activity
Tidsramme: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
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.
Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Wrist-worn accelerometer
Tidsramme: Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)
Objectively, physical activity will be measured with the use of a wrist-worn accelerometer (GeneActiv monitor) over 7 consecutive days.
Baseline(week 0), post intervention (week 8) and follow up (6-month post intervention)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Cambridge

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. juni 2022

Primær færdiggørelse (Faktiske)

21. september 2022

Studieafslutning (Forventet)

18. juni 2023

Datoer for studieregistrering

Først indsendt

2. februar 2022

Først indsendt, der opfyldte QC-kriterier

11. februar 2022

Først opslået (Faktiske)

23. februar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. november 2022

Sidst verificeret

1. november 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A096150

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