Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000795897
Ethics application status
Approved
Date submitted
9/04/2021
Date registered
24/06/2021
Date last updated
19/09/2023
Date data sharing statement initially provided
24/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Randomised Controlled Trial of SMS Text Messages to Support Tapering Opioids for Chronic Pain
Scientific title
A Pilot Randomised Controlled Trial of SMS Text Messages to Support Self-Tapering of Opioids for adults with Chronic Pain
Secondary ID [1] 303888 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 321463 0
Opioid Analgesics 321481 0
Opioid Tapering 321482 0
Condition category
Condition code
Anaesthesiology 319227 319227 0 0
Pain management
Public Health 319865 319865 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with chronic non-cancer pain on long term opioid therapy who are tapering opioids will be randomised to receive either a text message and video intervention in addition to usual care or usual care alone, for 4 weeks.

Participants randomised to the intervention group will initially receive an educational video (about chronic pain and opioid tapering) of approximately 10 minutes to watch that contextualizes the text messages they will be receiving. The video will be followed by text messages sent to their mobile phone for four weeks, twice per day including weekends. Messages will be sent at random times between 9 AM and 5 PM.

The library of text messages are intended to increase the recipient’s self-efficacy to taper opioids. The domains covered by the texts include validation, motivation, education and some advice and support on the key domains of pain, withdrawal symptoms, function/quality of life, mood and tapering. All participants in the intervention group will receive the same messages in the same order. Participants will not be expected or required to respond to the SMS system. Participants will be instructed that their responses will not be replied to.

Participants in the intervention group will receive all scheduled messages, unless they choose to withdraw from the study. Delivery of the messages (and responses, if any) will be recorded automatically on the text messaging system. If a message was not delivered, a second message will be sent. Participants can also withdraw from receiving the intervention by replying “STOP” to the text messages at any time. The trial coordinator will then contact the participant to ascertain if the participant is fully withdrawing from the study or just from receiving text messages but will continue to complete the follow-up data collections.
Intervention code [1] 320196 0
Behaviour
Comparator / control treatment
The control group will receive usual care from a multidisciplinary team (and any other health providers not affiliated with the research clinic who are involved in their care) to continue opioid tapering. They will not receive any interventional text messages nor watch the explanatory video. Usual care may include: physiotherapy, cognitive behavioural therapy with a clinical psychologist, medical treatment (GP or pain physician) and self guided pain self-management treatment (e.g. books).
Control group
Active

Outcomes
Primary outcome [1] 327105 0
The primary feasibility outcome is patient acceptability.
The primary objectives of this pilot RCT are to a) evaluate the feasibility of an mHealth intervention designed to improve opioid tapering self-efficacy in patients with chronic noncancer pain and b) evaluate the feasibility of a future trial methodology. Several feasibility measures will be evaluated in this study with the acceptability being the main feasibility measure in this pilot trial. The main question in this survey reflecting acceptability is whether participants would recommend the intervention to be used for supporting patients with chronic noncancer pain during opioid tapering. This question will be asked within a questionnaire designed specifically for this study to evaluate acceptability/feasibility.
Timepoint [1] 327105 0
To assess acceptability of the intervention, participants in the intervention group will be surveyed at the end of week 4.
Primary outcome [2] 330353 0
The primary measure for evaluating potential efficacy is change in opioid tapering self-efficacy. This will be measured using a single-item questionnaire developed for this study (OTSEQ, Opioid Tapering Self-Efficacy Questionnaire). It is based on Bandura’s self-efficacy theory and guides for constructing self-efficacy scales. The scale consists of one item: "How confident are you at the present time that you can reduce your dose of opioid medication?" Response is confidence level ranging in 10-percentile intervals from 0% (anchored as ‘not at all confident’) to 100% (anchored as ‘completely confident’). The face validity of the scale was evaluated by a panel of clinicians with experience in pain management and/or opioid tapering. Cognitive debriefing and further edition were done after interviewing with 6 patients.
Timepoint [2] 330353 0
Opioid tapering self-efficacy will be measured at baseline prior to randomization and then at the end of each week of the trial (end of Week 1, 2, 3, and 4). Note: Only the intervention group will repeat answer to the OTSEQ after viewing the education video.
Secondary outcome [1] 393805 0
Change in opioid dose: At baseline participants will self-report their medication (drug names, doses, regimen). During the trial, participants will be asked whether they had any change in their opioid dose in the past week using an open-ended question, and if yes, to name the medications and specify the dose changes: The total daily opioid use will be expressed in mg of oral morphine equivalents (OME) using the Faculty of Pain Medicine’s opioid calculator (www.opioidcaculator.com.au).
Timepoint [1] 393805 0
Completed at baseline prior to randomisation and then at the end of each week of the intervention period (weeks 1-4).
Secondary outcome [2] 393806 0
Change in pain intensity: Participants will complete the Pain, Enjoyment of Life and General Activity scale (PEG) (Krebs et al, 2009). The 3-item PEG scale measures intensity of pain (on average) and interference of pain with enjoyment of life and general activity in the past week, using 11-point (0-10) numerical rating scales (NRS), 0 being ‘no pain’ / ’does not interfere’ and 10 being ‘pain as bad as you can imagine’ / ’completely interferes’.
Timepoint [2] 393806 0
Pain intensity will be measured at baseline prior to randomisation and then at the end of each week of the trial (end of Week 1, 2, 3, and 4).
Secondary outcome [3] 393807 0
Change in pain interference: Participants will complete the Pain, Enjoyment of Life and General Activity scale (PEG) (Krebs et al, 2009). The 3-item PEG scale measures intensity of pain (on average) and interference of pain with enjoyment of life and general activity in the past week, using 11-point (0-10) numerical rating scales (NRS), 0 being ‘no pain’ / ’does not interfere’ and 10 being ‘pain as bad as you can imagine’ / ’completely interferes’.
Timepoint [3] 393807 0
Pain interference will be measured at baseline prior to randomisation and then at the end of each week of the trial (end of Week 1, 2, 3, and 4).
Secondary outcome [4] 393808 0
Mood/Distress: Participants will complete the Generalised Anxiety Disorder 2-item (GAD-2) (Korenke, Spitzer, Williams, & Monahan, 2007) and Patient Health Questionaire-2 (PHQ-2) (Kroenke, Spitzter & Williams, 2003) for weekly assessments. Each questionnaire contains 2 items screening anxiety and depression symptoms respectively and responses range from ‘Not at all’ = 0 to ‘Nearly every day’ = 3
Timepoint [4] 393808 0
The GAD-2 and PHQ-2 will be administered at baseline prior to randomisation and then end of each week of the trial (end of Week 1, 2, 3, and 4).
Secondary outcome [5] 393809 0
Withdrawal Symptoms: Using an open-ended question, participants will be asked if they had experienced any withdrawal symptom in the past week, and if yes, to explain. They also will be asked if they felt unwell in any other way in the past week and, if yes, to explain.
Timepoint [5] 393809 0
Withdrawal symptoms questions will be completed at baseline prior to randomization and then at the end of each week of the trial (end of Week 1, 2, 3, and 4)
Secondary outcome [6] 393810 0
Satisfaction with care
Participants will rate their current level of satisfaction with care with a 7-point Likert scale ranging from very dissatisfied to very satisfied (Darnall et al., 2020). They may also input free text responses
Timepoint [6] 393810 0
The Satisfaction with Care scale will be administered at the end of week 4 of the trial.
Secondary outcome [7] 393812 0
Pain Catastrophizing: Participants will self-report their current thoughts and feelings about managing their pain using the 6-item Concerns about Pain Scale (CAP-6, Amtmann et al., 2020) which is a new measure of pain catastrophizing developed using modern psychometric methodology.
Timepoint [7] 393812 0
The CAP-6 will be administered at baseline prior to randomisation and then at the end of week 4 of the trial.
Secondary outcome [8] 393813 0
Pain self-efficacy
Participants will self-report their current confidence to do things despite their pain with the Pain Self-Efficacy Questionnaire (PSEQ) (Nicholas, 2007). This 10-item measure assesses confidence in ability to do tasks and activities despite pain. Scores can range from 0 to 60, with lower scores indicating low levels of confidence for functioning despite pain.
Timepoint [8] 393813 0
The PSEQ will be administered at baseline prior to randomisation and then at the end of week 4 of the intervention period.
Secondary outcome [9] 405921 0
Dropouts, message delivery, missing data as other feasibility measures in addition to acceptability will be assessed by objective measures.
Dropouts will be recorded in the data management software after participants notify trial staff (telephone or email), message delivery (sent/failed to send) is recorded through the text messaging platform, missing data and study records audits will be conducted within REDCap the platform selected for data collection/management for this study.
Timepoint [9] 405921 0
At the end of week 4.

Eligibility
Key inclusion criteria
• Age 18 years or older.
• Diagnosed with a chronic (> 3 months) pain condition according to the International Classification of Diseases - 11th Revision.
• Have been using opioid analgesics at a dose of at least 40 mg/day Oral Morphine Equivalent for at least four weeks (i.e. participants are likely to have developed a certain level of physical tolerance).35 36
• Have been advised by a clinician to taper opioids.
• Are voluntarily tapering opioid medications, as indicated by verbalised willingness and consent.
• Be currently tapering or will be tapering their opioid medications at the time of enrolment. There is no restriction on how many times patients may have attempted opioid tapering, nor is there any restriction of the period of time participants may have been tapering before entering the study.
• Able to understand written and spoken English.
• Own a mobile phone that receives SMS.
• Able to give written informed consent and comply with study procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Cognitive impairment or intellectual disability preventing adherence to the study procedure.
• Evidence of severe opioid use disorder, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Illicit substance use, including illicit opioid use, is not an exclusion criterion, however if it fits a wider pattern of symptoms indicating a severe opioid use disorder it may inform a decision that the participant is ineligible for the study.
• History of primary psychotic disorder, bipolar affective disorder, bipolar disorder with psychotic features, depressive disorder with psychotic features, borderline personality disorder, antisocial personality disorder, or a positive family history (first degree relative) of psychotic disorder or bipolar affective disorder such that participants might be at more than low/negligible risk by participating in the study.
• Any other major, poorly controlled medical or mental health comorbidity.
• Participation in another clinical trial concurrently, since this will not constitute ‘usual care’ and can interfere with the study primary and secondary objectives by increasing the burden to patients and influencing estimates.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
RA1 will randomly allocate the participant to the study groups based on the randomization table in the REDCap. The randomization table (using block randomization based on the study site) will be generated at the beginning of the study by an independent member of the Clinical Trial Unit. Only the independent member of the PMRC Clinical Trial Unit will hold a copy of and have access to the randomization table (access to this table in REDCap will be limited for the research team members). RA1 has no access to the randomization table and only can see the assigned group after allocation by REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization table (using block randomization based on the study site) will be generated at the beginning of the study by an independent member of the Clinical Trial Unit using the Research Randomizer software and then will be uploaded to the REDCap.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size was considered 20 in each study arm. This sample size is appropriate for the study primary and secondary objectives. Aiming for the intervention to be acceptable by 70% of the participants with 20% precision (i.e. at least 50% would recommend the intervention), 18 participants are required in the intervention arm. To evaluate the potential efficacy of the intervention as compared with the control and assuming a medium standardised effect size (0.5), 12 participants are required in each group with 80% one-sided confidence interval approach which is suggested for pilot trials. To gather data to obtain estimates and calculate sample size for the future definitive trial, the recommended sample size for each study arm is 15 for a medium (0.5) standardised effect size. We also expect a loss to follow-up rate of 10% during the study period. Accordingly, the total sample size was calculated as 40.
For feasibility and acceptability measures, descriptive statistics will be used. To maintain blindness, a separate database of these measures will be generated without record ID, demographic data, or group ID.
For the comparison of the potential efficacy measures between the study groups, all analyses will be blinded to the group status. In this pilot trial the focus is on descriptive statistics and estimation, using confidence intervals, rather than formal hypothesis testing. Therefore, the confidence interval will be adjusted to 80% and one-sided. Descriptive statistics of demographics and all study variables over the 4 weeks will be reported. Mixed-model analysis will be used to test for the effect of Group x Time interaction for dependent variables of opioid tapering self-efficacy, pain intensity and interference, and mood. In all mixed model analyses, normal distribution of the residuals will be tested, and data will be transformed if needed to approximate residuals to normality. Mann-Whitney U test will be used for comparing the cumulative incidence of withdrawal symptoms and satisfaction. Correlation analysis (Pearson or Spearman correlation coefficients) will be done to find factors associated with opioid tapering self-efficacy. Analysis will be done using SAS software (v 9.4).52

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2021
Actual
25/08/2021
Date of last participant enrolment
Anticipated
1/05/2022
Actual
20/10/2022
Date of last data collection
Anticipated
1/06/2022
Actual
21/11/2022
Sample size
Target
40
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 19065 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 21650 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 25568 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 33615 0
2065 - St Leonards
Recruitment postcode(s) [2] 36693 0
2050 - Camperdown
Recruitment postcode(s) [3] 41389 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 308278 0
University
Name [1] 308278 0
Pain Management Research Institute, Faculty of Medicine & Health, The University of Sydney.
Country [1] 308278 0
Australia
Primary sponsor type
University
Name
Pain Management Research Institute, Faculty of Medicine & Health, The University of Sydney.
Address
PMRI, Ground Floor, Douglas Building, Royal North Shore Hospital, 1 Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 309090 0
None
Name [1] 309090 0
Address [1] 309090 0
Country [1] 309090 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308253 0
Northern Sydney Local Health District Human Ethics Committee
Ethics committee address [1] 308253 0
Ethics committee country [1] 308253 0
Australia
Date submitted for ethics approval [1] 308253 0
14/12/2020
Approval date [1] 308253 0
21/12/2020
Ethics approval number [1] 308253 0
2020/ETH03288

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110086 0
Prof Paul Glare
Address 110086 0
Pain Management Research Institute Ground floor, Douglas Building, Royal North Shore Hospital, 1 Reserve Road, ST LEONARDS, NSW, 2065
Country 110086 0
Australia
Phone 110086 0
+61 2 9463 1526
Fax 110086 0
+61 2 9463 1050
Email 110086 0
[email protected]
Contact person for public queries
Name 110087 0
Michael Magee
Address 110087 0
Pain Management Research Institute Ground floor, Douglas Building, Royal North Shore Hospital, 1 Reserve Road, ST LEONARDS, NSW, 2065
Country 110087 0
Australia
Phone 110087 0
+61 2 9463 1527
Fax 110087 0
+61 2 9463 1050
Email 110087 0
[email protected]
Contact person for scientific queries
Name 110088 0
Michael Magee
Address 110088 0
Pain Management Research Institute Ground floor, Douglas Building, Royal North Shore Hospital, 1 Reserve Road, ST LEONARDS, NSW, 2065
Country 110088 0
Australia
Phone 110088 0
+61 2 9463 1527
Fax 110088 0
+61 2 9463 1050
Email 110088 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not in ethics approval


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluating acceptability and feasibility of a mobile health intervention to improve self-efficacy in prescription opioid tapering in patients with chronic pain: Protocol for a pilot randomised, single-blind, controlled trial.2022https://dx.doi.org/10.1136/bmjopen-2021-057174
N.B. These documents automatically identified may not have been verified by the study sponsor.