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

1 novembre 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
      • Cambridge, Regno Unito, CB2 0SZ
        • Department of Psychiatry

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention group

The experimental group will receive:

Online education modules Online group discussions facilitated by Specialist Physiotherapist
Altro: KEEP Intervention
Educational intervention
Comparatore attivo: 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.
Altro: control
booklet from Parkinson's UK

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acceptability assessment 1: Recruitment rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Through study completion (12 months)
Assessment of any technical problems or difficulties accessing online intervention as reported by participants
Through study completion (12 months)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Unified Parkinson's Disease Rating Scale Part 3
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Cambridge

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 giugno 2022

Completamento primario (Effettivo)

21 settembre 2022

Completamento dello studio (Anticipato)

18 giugno 2023

Date di iscrizione allo studio

Primo inviato

2 febbraio 2022

Primo inviato che soddisfa i criteri di controllo qualità

11 febbraio 2022

Primo Inserito (Effettivo)

23 febbraio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 novembre 2022

Ultimo verificato

1 novembre 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A096150

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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