A Reminder App for Supporting Adherence to Treatment Goals in Parkinson's Disease

September 22, 2022 updated by: NHS Greater Glasgow and Clyde

A Single Case Experimental Design Study of a Reminder App for Supporting Adherence to Personalised Treatment Goals in Parkinson's Disease

Parkinson's Disease is a progressive condition which affects the nervous system causing tremors, slowed movement and often causes problems with memory and initiation. Treatment management can be complex and challenging for patients and families. Poor memory in Parkinson's disease has been shown to reduce a person's ability to manage activities of daily living, including tasks associated with treatment such a taking medications. However, patients with Parkinson's have been shown to benefit from external reminders.

The aim of this research project is to investigate whether the use of a reminder app that has been designed for use by people with cognitive difficulties improves completion of activities related to therapy goals in people with Parkinson's Disease, aiding self-management of their condition.

Patients seen in movement disorder clinics in NHS Greater Glasgow and Clyde with a diagnosis of Parkinson's disease, and a partner or carer who can monitor progress, will be invited to participate. Measures of memory, emotional wellbeing and quality of life will be completed to characterise each participant. Participants will have a randomly allocated initial baseline period of either 10, 16 or 22 days in which their rate of completion of intended activities will be monitored. Then, during the intervention period of 3 weeks (21 days) the ApplTree app will be introduced to remind participants of treatment goals. Participants will create specific and personalised treatment goals at the beginning of the monitoring period. Goals will be everyday activities relevant to the management and treatment of Parkinson's disease. The number of goals is not limited and will depend on how frequent targeted behaviours are. However, at least one target behaviour a day in total will be recommended. E.g. Completing daily exercises. Partners will monitor their goal attainment, via a daily/weekly monitoring form in both phases of the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aims:

The aim of this project is to investigate whether the use of a recently developed reminder app ApplTree improves attainment of personalised specific treatment goals in people with Parkinson's disease (PD).

Hypothesis:

The hypothesis of this study is that introduction of the reminder app will significantly improve attainment of treatment goals.

Methods

Design:

A single case experimental design (SCED) will be utilised with multiple baselines across participants with randomisation of the onset of the intervention phase for each participant.

Participants:

Participants will have a clinical diagnosis of PD. Further, the Parkinson's care team or the individual will have expressed concerns about adherence or attainment of treatment goals. Due to the design of the study, participants will be required to own a smart phone and have a partner or significant other who is able to, and consents to, monitor and support the participant's goal attainment as the nominated person.

Recruitment:

PD patients will be recruited via the movement disorder teams and movement disorder neurology clinics in Greater Glasgow and Clyde NHS Trust (GGC) via their Parkinson's consultant, named Parkinson's nurse specialist, occupational therapist, or physiotherapist within the team.

Measures:

Pre intervention measures:

All measures are validated for PD and recommended by the Movement Disorder Society (MDS).

  • A cognitive screen will be completed with all participants, the Montreal Cognitive Assessment.
  • Parkinson's Disease Quality of Life Questionnaire. A proxy-rating version will also be utilised.
  • Prospective and Retrospective Memory Questionnaire (PRMQ). A proxy-rating version of the PRMQ will also be utilised to alleviate limitations of self-report measures and build a broader picture.
  • Apathy Scale (AS).
  • Currently, no measure of anxiety is recommended by the MDS, therefore, the Generalised Anxiety Disorder severity index (GAD-7) and the Patient Health Questionnaire (PHQ-9) will be used to assess emotional wellbeing.

A weekly/daily monitoring form will be used by the partner during all phases of the intervention to record completion of intended goal related tasks (e.g., taking medication on time, completing prescribed exercises, nutritional snack, attending support group).

Procedure:

The study will run in batches of three participants, with replication of the design across the second set of three. The data collection phase for each participant will vary based on completing at least 5 data points within both the baseline and intervention phase and will range from 31-43 days for each participant. It is hoped that the timeframes for goals will require at least one reminder activity per day and so a two-day period will represent one datapoint. Participants will be assigned to a baseline period of 10, 16 or 22 days and an intervention period of 21 days (3 weeks).

Schedule:

  1. Members of the movement disorder teams in GGC will be asked to review caseloads for suitable participants, based on inclusion and exclusion criteria. Participants will have a diagnosis of Parkinson's disease, have a consenting partner or carer, have use of a mobile phone and have difficulty adhering to treatment goals.
  2. Potential participants and their carers/partners (nominated person) will be sent out the participant information sheet by post or be given them by a member of their clinical team during a clinic appointment. Potential participants will be able to indicate their willingness to discuss participation in the research with the researcher by returning a consent to be contacted form by pre-post to the researcher directly or by emailing the researcher informing them of their agreement for contact.
  3. Alternatively in cases where participant information is given in the appointment, participants can inform the clinical team member at their clinic appointment of their agreement for contact. In this instance staff will then send contact details of potential participants who have agreed for contact along to the researcher, via NHS secure email.
  4. Participants and nominated persons who consent to contact will be given a phone call to discuss the study in more detail and have the opportunity to ask any questions and, if ready, make a decision on whether they would like to participate and if undecided will be given a follow up call in 2 -5 days (depending on when is convenient for them). Inclusion and exclusion criteria will also be reviewed at this point to ensure eligibility.
  5. Eligible participants and nominated persons will then meet with the researcher initially to complete written consent form and pre intervention measures. This meeting will be either face-to-face in an NHS building, face-to-face in their own home or via video call, depending on participant preferences and travel limitations.
  6. Participants and nominated persons will then meet with the researcher a second time (Face-to-face or Video call) to discuss and formulate specific and personalised treatment/therapy goals. Discussion of goals will be informed by pre-intervention measures, partners and participants own views. Goals will be relevant to the management and treatment of Parkinson's Disease and have a memory and motivational component such as reminders for medication regime or physical exercises.
  7. A weekly monitoring form will then be given to participants' nominated person to record completion of intended goal related tasks (e.g., taking medication on time, completing prescribed exercises, nutritional snack, attending support group) and the baseline phase will begin for a duration of 10, 16 or 22 days the following day. The duration of the baseline phase will be randomly assigned using an online random number generator.
  8. The nominated person will receive a weekly reminder call to ensure the weekly monitoring form is being completed and to troubleshoot any problems.
  9. The nominated person will receive a reminder text on a daily basis to ensure the form is being completed daily.
  10. At the end of the baseline phase, participants and partners will meet with the researcher (Face to face or video call) to receive a training session on using the app and to input reminders for specific goal related actions.
  11. Participants will then start an intervention phase of 22 days and partners will continue to use the monitoring form provided.
  12. Participants will receive a weekly phone call to troubleshoot any problems.
  13. The nominated person will receive a reminder text on a daily basis to ensure the monitoring form is completed daily.
  14. At the end of the intervention stage participants and nominated persons will meet with the researcher a final time for a debrief (face-to-face or video call).

Setting:

Meetings with participants will be in an agreed NHS building, remote video call via attend anywhere, or in some cases in the participants own home. Due to the nature of health conditions and travel limitations within the population, the preferences of the participant and their nominated person will be given priority for arranging meetings. Current Scottish government/NHS GG&C guidance surrounding COVID-19 will also be taken into account. Telephone calls and video calls will be completed by the researcher from an NHS premises, to ensure confidentiality of data collected.

Materials:

ApplTree is a reminding app designed to be used by people with cognitive impairments as a result of acquired brain injury. ApplTree has a narrow/deep user interface design which presents a small amount of information at a time to minimise the burden on people with cognitive impairment. Each participant will download the ApplTree app onto their own smart device. The app is free to use and maintained by Glasgow University Software Services (GUSS).

Analysis Plan:

The primary outcome measure will be the percentage of goal related tasks carried out independently (i.e., without prompting from another person) per two-day period. The primary outcome is measured via the daily monitoring form, completed by participant's nominated person. In line with recommendations for analysis of SCED data, the data will be analysed through visual analysis of graphs and Tau-U analysis to determine whether a significant improvement is found between baseline and intervention phase.

Sample Size:

The Risk of Bias in N of 1 Trials (RoBiNT) recommends that SCED designs provide at least three demonstrations of the treatment effect. In a multiple baseline across participants design this means a minimum of three participants. Additionally, the RoBiNT highlights the importance of replication, referring to replication of the overall study, meaning replication of the set of three participants. Hence, the present study will aim to recruit a minimum of six participants, and to allow for possible withdrawals the aim will be to recruit nine participants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
        • NHS Greater Glasgow and Clyde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A clinical diagnosis of PD.
  • Participants will be required to own a smart phone
  • Have a partner or significant other who is able to, and consents to, monitor and support the participant's goal attainment through daily monitoring forms.
  • Possible concerns around adherence or attainment of treatment goals by Movement disorder team, patient or significant other

Exclusion Criteria:

  • A diagnosis of dementia
  • Pre-existing neurological or severe and enduring psychiatric disorder.
  • Do not own a smart phone capable of downloading apps.
  • Sensory deficits preventing the use of a smart device/phone.
  • Are currently involved in any other research study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ApplTree Reminder app
Following a randomised baseline period, each participant will use the ApplTree reminder app for 22 days to support adherence to goal-related tasks
Device: ApplTree reminder app
The reminder app will be introduced to participants to support adherence to chosen goal-related tasks. Reminder app will be introduced following a baseline phase of 10, 16 or 22 days. The duration of the baseline phase will be randomly assigned using an online random number generator.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Goal-related tasks completed
Time Frame: 22 days
The primary outcome measure will be the percentage of goal related tasks carried out independently (i.e., without prompting from another person) per two-day period. The primary outcome is measured via the daily monitoring form, completed by participant's nominated person.
22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Greater Glasgow and Clyde

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GN21NE440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

It is standard practice in reporting SCED studies to provide raw data for each participant within the study write up. This means that data are available for future researchers (e.g. for the purpose of meta-analysis). Care will be taken to ensure included data ensures anonymity of participants and that demographic information is kept to a minimum so that they cannot be identified from the data.

IPD Sharing Time Frame

Upon publication

IPD Sharing Access Criteria

Individual patient date are routinely reported in study outputs from Single Case Experimental Design studies, in line with methodological and reporting quality guidelines.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on ApplTree reminder app

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings