Evidence map›Paper›PMID 39527590›Full record

ArticlePloS one2024

A single-blind, randomised control trial on the effectiveness of a structured multi component training module for family caregiver of persons with Parkinson's disease: A study protocol.

Nur Izyan Mohd Amin, Nor Azlin Mohd Nordin, Aniza Ismail, Sharmila Gopala Krishna Pillai, Hanif Farhan Mohd Rasdi

Abstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Nur Izyan Mohd AminCenter for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.ORCID 0009-0007-1402-6745
Nor Azlin Mohd NordinCenter for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Aniza IsmailDepartment of Public Health Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia Medical Centre, Cheras, Kuala Lumpur, Malaysia.
Sharmila Gopala Krishna PillaiCenter for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.
Hanif Farhan Mohd RasdiCenter for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionParkinson disease (PD), a neurodegenerative disorder that progresses over time, is steadily growing in number and prevalence worldwide. PD in Malaysia is expected to increase five-fold by 2040 from the existing estimate of 20,000 patients in 2018. Treatment program of PD in Malaysia is rather unstructured, and there is no known comprehensive PD family caregiver training program available to date. To ensure the quality of a program, it must be tested for feasibility, effectiveness and sustainability. This paper describes the protocol of a study that evaluates the effectiveness of a structured, comprehensive training program of family caregiver to persons with PD in comparison to usual care. MATERIALS AND METHODS–STUDY PROTOCOL: A total of 60 pairs of persons with PD of stage II and III, and their primary family caregiver will be recruited and allocated into either an experimental or a control group for 12 weeks of intervention. The experimental group will undergo initial training from multi-disciplinary healthcare providers and will be given a physical module containing weekly tasks that must be practised at home. While the control group will receive a usual care. Both groups will be assessed in terms of physical functions, functional mobility, quality of life (QoL), caregiver burden and knowledge using standardised assessment tools namely Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Timed Up and Go (TUG) test, Parkinson's Disease Questionnaire (PDQ-39), European Quality of Life five-dimensions (EQ-5D), Malay version of Zarit Burden Interview (MZBI) and Knowledge of Parkinson Disease Questionnaire (KPDQ). In addition, the feasibility and sustainability of the interventions will be evaluated, alongside its cost-effectiveness based on the average and incremental cost effectiveness ratio. All data will be analysed using descriptive and inferential statistics, particularly mixed model ANOVA. DISCUSSION: There is a significant gap in the literature pertaining family caregiver training programs for people with PD. Documented programs are lacking in term of comprehensiveness of content, application approach and the measurement of training outcomes including the program cost-effectiveness. The feasibility and effectiveness of such training program in a Malaysian setting also requires investigation due to differences in living environment, support system and population's perception. This study will assist to fulfil the existing literature gap and demonstrate the potential benefit of caregiver involvement in mediating the care and therapy for PD in the home setting. Optimum knowledge and skills gained through the training are expected to enhance the confidence and ability of the family caregivers and may possibly reduce their perceived caregiving burden. PROTOCOL REGISTRATION: The protocol of this study is registered in the Australian-New Zealand Clinical Trial Registry (ANZCTR) with a registration number ACTRN12623000336684.

Indexed as

CaregiversParkinson DiseaseQuality of LifeFemaleHumansMalaysiaMaleRandomized Controlled Trials as TopicSingle-Blind Method

Identifiers

PMID39527590
PMCPMC11554143

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.