DockTales for Chronic Pain
Evaluating Feasibility and Acceptability of DockTales for Chronic Pain
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a fully remote, randomized crossover pilot clinical trial designed to evaluate the feasibility and acceptability of DockTales among adults with chronic pain. Chronic pain is defined as pain lasting for more than 3 months. A total of up to 60 participants will be enrolled.
Participants will be randomized in a 1:1 ratio to one of two study sequences. Participants assigned to Sequence 1 will complete 2 weeks of DockTales use followed by 2 weeks of REDCap-based daily monitoring. Participants assigned to Sequence 2 will complete 2 weeks of REDCap-based daily monitoring followed by 2 weeks of DockTales use. All participants will complete both study conditions.
Participants will complete questionnaires at baseline, after the first 2-week period, and after the second 2-week period. These assessments will evaluate feasibility, acceptability, usability, burden, engagement, technical issues, participant preference, and exploratory pain and sleep-related outcomes. Some participants may also complete an optional remote semi-structured interview after finishing both study conditions.
The primary outcomes are feasibility and acceptability. Feasibility will be assessed through recruitment, retention, adherence, completion of DockTales use, completion of REDCap monitoring, missing data, and technical issues. Acceptability will be assessed through satisfaction, engagement, perceived usefulness, ease of use, burden, willingness to use DockTales again, and preference between DockTales and REDCap monitoring.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Yang Wang, PhD
- Telefoonnummer: 410-706-7824
- E-mail: yang.wang@umaryland.edu
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- University of Maryland Baltimore School of Nursing
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Hoofdonderzoeker:
- Yang Wang, PhD
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Contact:
- Yang Wang
- Telefoonnummer: 410-706-7824
- E-mail: yang.wang@umaryland.edu
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Contact:
- Rachel Massalee, MS
- Telefoonnummer: 410-706-7824
- E-mail: rmassalee@umaryland.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Age ( 18-88 years old)
- English speaker (written and spoken)
- Chronic pain for at least 3 months
- Smartphone/text messaging capability
Exclusion Criteria:
- Any personal history of mania, schizophrenia, or other psychoses
- Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, autism) leading to hospitalization within the last 3 years.
- Pregnancy or breast feeding
- Impaired or uncorrected hearing
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: DockTales first
This is a crossover-designed study with one arm of chronic pain participants.
All participants will complete both active (DockTales) and control (REDCap) interventions in a randomized sequence.
The first arm will complete 2 weeks of DockTales first, and 2 weeks of REDCap monitoring
|
DockTales includes several core features:
The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
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Ander: REDCap first
This is a crossover-designed study.
Participants in this arm will start with 2 weeks of REDCap monitoring, followed by 2 weeks of DockTales use
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DockTales includes several core features:
The focus of the DockTales intervention is to support self-monitoring, reflection, engagement, and user experience among adults with chronic pain.
REDCap will be used to monitor daily symptoms and diaries from people with chronic pain.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Enrollment rate
Tijdsspanne: At the enrollment
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Enrollment rate: the proportion (%) of recruited participants who enrolled in the study.
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At the enrollment
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Retention rate
Tijdsspanne: End of Week 4
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Retention rate: the proportion (%) of enrolled participants who finished the study
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End of Week 4
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Module completion rate
Tijdsspanne: End of Week 4
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Module rate: the proportion (%) of completed modules in the DockTales app.
The DockTales app contains 1) daily monitoring module; 2) navigation map module; 3) AI avatar companion module; and 4) daily dairy module.
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End of Week 4
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Daily survey completion rate
Tijdsspanne: End of Week 4
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Module rate: the proportion (%) of completed daily surveys sent through DockTales and REDCap-based surveys.
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End of Week 4
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Levels of satisfaction
Tijdsspanne: End of Week 2 and Week 4
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Levels of satisfaction are assessed using a visual analogue scale ranging from 0 = not satisfied at all to 100 = extremely satisfied.
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End of Week 2 and Week 4
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Levels of enjoyment
Tijdsspanne: End of Week 2 and Week 4
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Levels of enjoyment are assessed using a visual analogue scale ranging from 0 = not enjoyed at all to 100 = extremely enjoyed.
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End of Week 2 and Week 4
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Levels of engagement
Tijdsspanne: End of Week 2 and Week 4
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Levels of engagement are assessed using a visual analogue scale ranging from 0 = not engaged at all to 100 = extremely engaged.
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End of Week 2 and Week 4
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HP-00119506
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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