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

NCT05106985 | Completed

• 1 other identifier: GN21NE440
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• Goal-related tasks completed

  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

Study Arms (1)

ApplTree Reminder app

EXPERIMENTAL

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

Interventions

ApplTree reminder app DEVICE

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.

ApplTree Reminder app

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

Related Publications (8)

• Jamieson M, Cullen B, Lennon M, Brewster S, Evans J. Designing ApplTree: usable scheduling software for people with cognitive impairments. Disabil Rehabil Assist Technol. 2022 Apr;17(3):338-348. doi: 10.1080/17483107.2020.1785560. Epub 2020 Jul 7.

  PMID: 32633592 BACKGROUND

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  PMID: 24050810 BACKGROUND

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  PMID: 21496513 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Starkstein SE, Mayberg HS, Preziosi TJ, Andrezejewski P, Leiguarda R, Robinson RG. Reliability, validity, and clinical correlates of apathy in Parkinson's disease. J Neuropsychiatry Clin Neurosci. 1992 Spring;4(2):134-9. doi: 10.1176/jnp.4.2.134.

  PMID: 1627973 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.

  PMID: 10568646 BACKGROUND

• Peto V, Jenkinson C, Fitzpatrick R. PDQ-39: a review of the development, validation and application of a Parkinson's disease quality of life questionnaire and its associated measures. J Neurol. 1998 May;245 Suppl 1:S10-4. doi: 10.1007/pl00007730.

  PMID: 9617716 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jonathan Evans

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single case experimental design: Multiple Baseline Design

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 4, 2021
• Study Start: January 20, 2022
• Primary Completion: July 30, 2022
• Study Completion: September 2, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Upon publication
• 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.

Locations

GB (1)