NCT05102578

Brief Summary

Persistent pain describes long term pain that is present nearly every day. It is common and affects millions of people in the United Kingdom. The investigators want to explore people's experience of living with persistent pain and investigate how pharmacists can help people manage their pain. For this, the investigators will be testing a digital Decision Aid Tool (DAT) that includes a pain and lifestyle assessment as part of a pain consultation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 1, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

December 6, 2023

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

June 10, 2021

Last Update Submit

November 29, 2023

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

  • Pain assessed using the Chronic Pain Grade

    Self-administered questionnaire that records subscale scores for pain intensity and disability are combined to calculate a chronic pain grade that enables classification of chronic pain patients.

    6 weeks

  • EuroQol's 5D-5L

    Self-administered questionnaire that records state and quality of life using EuroQol's five dimensions and 5 levels.

    6 weeks

  • Personal Well-being Scale

    Self-administered questionnaire that records personal wellbeing using the UK's Office of National Statistics (ONS) Measuring Subjective Well-being for Public Policy.

    6 weeks

Study Arms (2)

Standard Care

NO INTERVENTION

Usual care. Consultation with pharmacist with no decision aid tool.

Digital Decision Aid Tool

EXPERIMENTAL

Consultation with pharmacist using the digital decision aid tool.

Behavioral: Digital Decision Aid Tool

Interventions

Digital Decision Aid ToolBEHAVIORAL

The digital DAT will ask people about their current pain levels, medications and physical activity. Following this, it will include a Discrete Choice Experiment (DCE)-like component with a series of questions that ask users to choose between different pain management packages. Similar to a standard DCE, packages (or plans) are described by attributes and levels, which include broad categories of guideline-based pain management strategies routinely available in clinical practice. The descriptors used for the attributes and levels were informed by a previous qualitative research study and based on therapeutic options that are helpful and important to people with persistent pain .

Digital Decision Aid Tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years old.
  • Suffer from non-malignant persistent pain (defined as pain lasting for more than three months).
  • Managed entirely within a primary care setting.

You may not qualify if:

  • Not fluent in the English language.
  • Have concomitant severe mental health problems or terminal illness.
  • Suffer from pain caused by cancer or other malignancy.
  • Not able to give informed consent (e.g. because of mental state)
  • Takes part in another research study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NHS Grampian

Aberdeen, United Kingdom

Location

University of Aberdeen

Aberdeen, United Kingdom

Location

Related Publications (1)

  • Loria-Rebolledo LE, Ryan M, Bond C, Porteous T, Murchie P, Adam R. Using a discrete choice experiment to develop a decision aid tool to inform the management of persistent pain in pharmacy: a protocol for a randomised feasibility study. BMJ Open. 2022 Sep 22;12(9):e066379. doi: 10.1136/bmjopen-2022-066379.

    PMID: 36137622DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mandy Prof Ryan

    HERU Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2021

First Posted

November 1, 2021

Study Start

January 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

December 6, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Any data shared with other researchers will be anonymised.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Beginning 9 months and ending 36 months following article publication.
Access Criteria
Individual participant data (after de-identification) that underlie the results of this study will be available upon reasonable requests to investigators whose proposed used of data has been approved by an independent review committee identified for this purpose.
More information

Locations

GB(2)