Parkinson DiseaseNCT03111472
Development and Evaluation of a Guide to Help People With Parkinson's and Their Caregivers to Self-manage Falling
A study testing Self-management guide for people with Parkinson's who fall and their informal caregivers in people with Parkinson Disease and Accidental Fall, run by University of Southampton at 1 site in United Kingdom.
Trial summary
This study will investigate whether it is possible, through the development and evaluation of a self-management guide, to improve health related quality of life and concern of falling in people with Parkinson's disease who fall, and reduce caregiver burden in their informal caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Accidental Fall
- What is being tested?
- Self-management guide for people with Parkinson's who fall and their informal caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease, with or without cognitive impairment
- People with Parkinson's living in their own home
- At least one fall in the preceding year, as reported by the person with Parkinson's or the caregiver
- Able to read a newspaper without severe difficulty, with or without glasses
- OR
- An informal caregiver of a person with Parkinson's meeting the criteria for inclusion in the study
Who cannot join
- Diagnosis of a Parkinson's Plus syndrome
- People with Parkinson's living in a residential or nursing home
- No falls in the preceding year
- Non-fluent in verbal and written English
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Southampton
Southampton, Hampshire, SO17 1BJ
About this study
Official title: Development and Evaluation of a Self-management Guide for Community-dwelling People With Parkinson's Disease Who Fall and Their Informal Caregivers
This study will investigate whether it is possible, through the development and evaluation of a self-management guide, to improve health related quality of life and concern of falling in people with Parkinson's disease who fall, and reduce caregiver burden in their informal caregivers.
Read the detailed description
This study will progress through four phases
Phase One
Establish the needs and preferences of people with Parkinson's (PwP) who fall and their informal caregivers for the effective self-management of falls. This will be achieved through questionnaires distributed to 30-40 PwP and their caregivers, with responses analysed through the use of descriptive statistics. A purposive sample of participants, selected through responses to the questionnaire, will be invited to participate in semi-structured interviews. Interviews will be conducted until data saturation has been achieved. These interviews will seek to further identify the thoughts and experiences of PwP and their caregivers in relation to falling, with responses analysed through thematic analysis.
Phase Two
Establish the needs and preferences of PwP who fall and their informal caregivers for the effective self-management of falls, as perceived by healthcare professionals specialising in the care of PwP. This will be achieved through semi-structured interviews and focus groups with 10 healthcare professionals involved in the care of PwP who fall. The interviews will be analysed with thematic analysis.
Phase Three
Development of a prototype of a self-management guide utilising information from phases one and two alongside a systematic review of self-management interventions for people with Parkinson's who fall. The prototype will be distributed to 6-8 dyads of PwP who fall and their caregivers. Feedback will be sought in the form of a questionnaire, with responses analysed through the use of descriptive statistics, and the guide modified accordingly.
Phase Four
Mixed methods acceptability and feasibility study of the modified version of the guide; with a before and after comparison of health related quality of life and concern of falling in PwP, and of caregiver burden in their informal caregivers.
The guide will be distributed to 30-40 pairings of PwP who fall and their caregivers. Baseline assessments of health related quality of life (Parkinson's disease questionnaire 8, PDQ8) and of caregiver burden (Zarit Burden Interview short version) will be completed.
After three months, participants will complete feedback questionnaires to assess the acceptability and the feasibility of the guide, and will repeat the PDQ8 and zarit burden Interview short version . The responses to the questionnaires will be analysed through the use of descriptive statistics, with a before and after comparison of health related quality of life and of caregiver burden.
A purposive sample of participants, selected through their responses to the questionnaires, will be invited to participate in semi-structured interviews, to further explore their thoughts about the guide. Interviews will be conducted until data saturation has been reached, we estimate that we will conduct 12-15 interviews. The interviews will be analysed using thematic analysis.
- Conditions
- Parkinson Disease, Accidental Fall
- Being tested
- Self-management guide for people with Parkinson's who fall and their informal caregivers
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management guide for people with Parkinson's who fall and their informal caregiversOther
The self-management guide will be developed utilising information from people with Parkinson's, informal caregivers of people with Parkinson's, healthcare professionals and a systematic review of self-management interventions for people with Parkinson's who fall.
| Study group | Role | What they receive |
|---|---|---|
| Self-management guide for falls in Parkinson's | Experimental | A guide for people with Parkinson's and their caregivers to self-manage falls. Receives: Other: Self-management guide for people with Parkinson's who fall and their informal caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of the guide
This will assessed through response to a questionnaire, with responses analysed through descriptive statistics
Measured: 3 months
Feasibility and acceptability of the guide
A purposive sample of participants, selected through their responses to the questionnaire, will be invited to participate in semi-structured interviews. Interviews will explore the experiences and thoughts of the participants further and will be conducted until data saturation has been reached. Responses to the interview will be analysed through thematic analysis.
Measured: 3 months
Secondary outcomes (2)
Health related quality of life of people with Parkinson's as measured on PDQ8
As measured on Parkinson's disease quality of life scale 8 (PDQ8)
Measured: 3 months
Caregiver burden of their informal caregivers as measured on the Zarit Burden Interview scale short version
As measured on the Zarit Burden Interview scale short form
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 May 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 30-40 participants will receive the intervention. The intervention will be a guide to help people with Parkinson's and their caregivers to self-manage falls. There will be no control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111472
- Sponsor's protocol ID
- 25364
- Status last verified
- Oct 2017
- First submitted
- 7 Mar 2017
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Self-management Guide for Community-dwelling People With Parkinson's Disease Who Fall and Their Informal Caregivers
- ClinicalTrials.gov ID
- NCT03111472
- Acronym / sponsor ID
- 25364
- Conditions
- Parkinson Disease, Accidental Fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 May 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether it is possible, through the development and evaluation of a self-management guide, to improve health related quality of life and concern of falling in people with Parkinson's disease who fall, and reduce caregiver burden in their informal caregivers.
Detailed description
This study will progress through four phases
Phase One
Establish the needs and preferences of people with Parkinson's (PwP) who fall and their informal caregivers for the effective self-management of falls. This will be achieved through questionnaires distributed to 30-40 PwP and their caregivers, with responses analysed through the use of descriptive statistics. A purposive sample of participants, selected through responses to the questionnaire, will be invited to participate in semi-structured interviews. Interviews will be conducted until data saturation has been achieved. These interviews will seek to further identify the thoughts and experiences of PwP and their caregivers in relation to falling, with responses analysed through thematic analysis.
Phase Two
Establish the needs and preferences of PwP who fall and their informal caregivers for the effective self-management of falls, as perceived by healthcare professionals specialising in the care of PwP. This will be achieved through semi-structured interviews and focus groups with 10 healthcare professionals involved in the care of PwP who fall. The interviews will be analysed with thematic analysis.
Phase Three
Development of a prototype of a self-management guide utilising information from phases one and two alongside a systematic review of self-management interventions for people with Parkinson's who fall. The prototype will be distributed to 6-8 dyads of PwP who fall and their caregivers. Feedback will be sought in the form of a questionnaire, with responses analysed through the use of descriptive statistics, and the guide modified accordingly.
Phase Four
Mixed methods acceptability and feasibility study of the modified version of the guide; with a before and after comparison of health related quality of life and concern of falling in PwP, and of caregiver burden in their informal caregivers.
The guide will be distributed to 30-40 pairings of PwP who fall and their caregivers. Baseline assessments of health related quality of life (Parkinson's disease questionnaire 8, PDQ8) and of caregiver burden (Zarit Burden Interview short version) will be completed.
After three months, participants will complete feedback questionnaires to assess the acceptability and the feasibility of the guide, and will repeat the PDQ8 and zarit burden Interview short version . The responses to the questionnaires will be analysed through the use of descriptive statistics, with a before and after comparison of health related quality of life and of caregiver burden.
A purposive sample of participants, selected through their responses to the questionnaires, will be invited to participate in semi-structured interviews, to further explore their thoughts about the guide. Interviews will be conducted until data saturation has been reached, we estimate that we will conduct 12-15 interviews. The interviews will be analysed using thematic analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 30-40 participants will receive the intervention. The intervention will be a guide to help people with Parkinson's and their caregivers to self-manage falls. There will be no control group.
| Arm | Type | Receives |
|---|---|---|
| Self-management guide for falls in Parkinson's | Experimental | Other: Self-management guide for people with Parkinson's who fall and their informal caregiversA guide for people with Parkinson's and their caregivers to self-manage falls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of idiopathic Parkinson's disease, with or without cognitive impairment
- People with Parkinson's living in their own home
- At least one fall in the preceding year, as reported by the person with Parkinson's or the caregiver
- Able to read a newspaper without severe difficulty, with or without glasses
- OR
Key exclusion criteria (4 listed)
- Diagnosis of a Parkinson's Plus syndrome
- People with Parkinson's living in a residential or nursing home
- No falls in the preceding year
- Non-fluent in verbal and written English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management guide for people with Parkinson's who fall and their informal caregiversThe self-management guide will be developed utilising information from people with Parkinson's, informal caregivers of people with Parkinson's, healthcare professionals and a systematic review of self-management interventions for people with Parkinson's who fall. | Other | Self-management guide for falls in Parkinson's |
Primary outcome
Feasibility and acceptability of the guide
Time frame: 3 months
This will assessed through response to a questionnaire, with responses analysed through descriptive statistics
Feasibility and acceptability of the guide
Time frame: 3 months
A purposive sample of participants, selected through their responses to the questionnaire, will be invited to participate in semi-structured interviews. Interviews will explore the experiences and thoughts of the participants further and will be conducted until data saturation has been reached. Responses to the interview will be analysed through thematic analysis.
2 secondary outcomes
Health related quality of life of people with Parkinson's as measured on PDQ8
Time frame: 3 months
Caregiver burden of their informal caregivers as measured on the Zarit Burden Interview scale short version
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management guide for people with Parkinson's who fall and their informal caregivers in people with Parkinson Disease and Accidental Fall, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the guide (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.