Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000397617
Ethics application status
Not required
Date submitted
3/04/2014
Date registered
11/04/2014
Date last updated
17/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The implementation of effective non-pharmacological interventions of the People Getting a Grip educational program for individuals with rheumatoid arthritis through different delivery methods: An International Online Knowledge Translation Randomized Controlled Trial
Scientific title
The implementation of effective non-pharmacological interventions of the People Getting a Grip educational program for individuals with rheumatoid arthritis through different delivery methods: An International Online Knowledge Translation Randomized Controlled Trial
Secondary ID [1] 284346 0
None
Universal Trial Number (UTN)
None
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 291499 0
Condition category
Condition code
Musculoskeletal 291868 291868 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291869 291869 0 0
Physiotherapy
Inflammatory and Immune System 292003 292003 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be five intervention groups in the proposed complex RCT. The duration of this study will be 12 months.

1) “PGrip (People Getting a Grip -RA (rheumatoid arthritis) TAS (The Arthritis Society) website URL link via Facebook Plus” (Group E):
Participants in the Facebook Plus (Group E) group will have access to a Facebook group page which will present the PGrip-RA Online program. PGrip-RA Online Facebook page will include video presentations of various effective RA self-management interventions strategies based on The Ottawa Panel evdence-based clinical guidelines. Video presentations will include narrated PowerPoint presentations with simplified concise instructions on how to perform/apply each self-management intervention and case scenarios illustrating the appropriateness and relevance of each. In addition, video presentations of practical sessions including a health professional describing step by step instructions while performing the evidence-based intervention will also be posted on each group page. Participants will have the opportunity to share their unique perspective on living with arthritis and how they plan to integrate the effective self-management interventions into their daily lives by posting comments using the “wall” tool on the Facebook page. Participants will have access to the online material after the completion of the baseline questionnaires to the final follow-up questionnaire at 6 months. Participants will participate in three separate self-management online modules over the course of two weeks consisting of 1) physical activity interventions, 2) wrist orthotics and foot insoles interventions, and 3) transcutaneous electrical nerve stimulation (TENS) module.
A group of three trained health professionals, representing three professions (physiotherapists, occupational therapists, and dietitians) from the Arthritis Health Profession Association (AHPA) will be asked to read the comments and questions participants write to each other and will then summarize and give feedback to the participants on a weekly basis. The Facebook page will be monitored by a health professional three times per week (Monday, Wednesday, and Friday) during the duration of each module. At this time they will review all of the participants’ written comments and summarize and provide feedback. The total intervention period is six weeks.

2) “PGrip-RA TAS website URL link via Facebook” (Group D):
Similarly to Group E, participants in the Facebook (Group D) group will have access to a Facebook group page (separate from Group E, without the participation of health professionals) and will participate in the three self-management modules over the course of two weeks. Participants will have access to the online material after the completion of the baseline questionnaires to the final follow-up questionnaire at 6 months. All participants in Group D will also be provided with TAS educational pamphlets on general self-management interventions for RA by posting a URL link for each on the Facebook page. The total intervention period is six weeks.

3)“PGrip-RA TAS website URL link via e-mail (No Facebook)” (Group C):
A third online intervention group (Group C) will consist of individuals being e-mailed a URL link to access the TAS PGrip-RA) website. This website will provide participants in this group with the same educational information that will be provided in the Facebook groups. Individuals in this group will not have access to the two Facebook group pages. They will not interact with each other or the health professionals through written messages. Participants will also be provided with TAS educational pamphlets on general self-management interventions for rheumatoid arthritis (RA). Group C will have to learn by themselves the content of the PGrip-RA module with no feedback. The total intervention period is six weeks.

4) “PGrip-RA workbook via e-mail (No Facebook) ”(Group B):
They will be e-mailed a workbook of similar quality and content of the PGrip-RA program in PDF document and the URL links of the electronic TAS educational pamphlets on general self-management interventions for RA. They will not have any access to the health professionals and they will not have access to any of the Facebook group page. Group B will have to learn by themselves the content of the PGrip-RA module with no feedback. The total intervention period is six weeks.

Based on data from our pilot study, we anticipate similar compliance rates. Only 1% of participants did not complete the baseline questionnaire and 20% did not complete the final 3-month follow-up questionnaire. To compensate for the proposed study, the sample size has been adjusted accordingly.
Intervention code [1] 289069 0
Rehabilitation
Intervention code [2] 289070 0
Behaviour
Intervention code [3] 289071 0
Treatment: Other
Comparator / control treatment
Control with TAS electronic educational pamphlets only (No PGrip-RA) via e-mail (No Facebook) (Group A)

To avoid inter-group contamination, participants in the control group will only be emailed the URL links of the TAS e-pamphlets on general self-management interventions for RA. They will not have any access to the PGrip-RA material or to the health professionals and they will not have access to the Facebook group page.
Control group
Active

Outcomes
Primary outcome [1] 291789 0
Self-efficacy to manage pain related to KnowledgeTranslation Action Cycle (KTAC) Evaluate Outcomes:
The measurement of self-efficacy will therefore capture the effectiveness of all interventions regardless of the specific type of self-management strategy. The Stanford Arthritis Self-Efficacy Scale (ASES)will be used to assess participants’ self-efficacy. The self-efficacy pain scale and self-efficacy of other symptoms scale of the ASES tool will be combined.
Timepoint [1] 291789 0
At baseline, 6 weeks immediate post-intervention, 3 and 6 months follow-up.
Secondary outcome [1] 307542 0
Knowledge acquisition, related to KTAC monitoring knowledge:
Knowledge acquisition will be measured using questionnaires used in the two pilot studies, i.e. Participants’ pre-program knowledge of the self-management interventions. Participants will be asked to complete a series of questions using a Likert scale to determine which self-management strategy options are effective for treating RA. A logbook will be filled out by each participant as KTAC Monitoring the knowledge using the 7-Day Physical Activity Readiness (PAR) calendar and a bi-weekly questionnaire on potential changes in physical activity(PA), medication intake, habits and adverse events.
Timepoint [1] 307542 0
At baseline, and post-program knowledge will be measured at 6 weeks immediate post intervention, 3 and 6 months follow-up
Secondary outcome [2] 307543 0
Intention to use the PGrip-RA and actual use the self-management interventions :
Intention to use of the PGrip-RA self-management interventions will be measured using questionnaires used in the two pilot studies. Question related to the participant's intention to use PGrip-RA self-management interventions will be based on the Ottawa Panel recommendation for each effective self-management intervention and mentioned clearly in the PGrip-RA video. For example, do you intent to use aquatic jogging (3 times a week; 60 minutes per session for 12 consecutive weeks as recommended by Ottawa Panel guidelines) in your daily life to self-manage your rheumatoid arthritis. This will be asked immediately after the 6-week intervention for each self-intervention contained in the PGrip-RA. Participants will be assessed as to whether they have any intention on using in each of the self-management intervention. Study participants in all 5 groups will be ask to set goals bi-weekly regarding any self-management interventions offered by PGrip-RA by themselves.
Timepoint [2] 307543 0
At 6 weeks immediate post-intervention
Secondary outcome [3] 307544 0
Actual use the PGrip-RA self-management interventions and information communication technology (ICT) related to KTAC Evaluate Outcomes:
Actual use of the PGrip-RA self-management interventions will be measured using questionnaires used in the two pilot studies, as to whether they actually participated in the PGrip-RA self-management interventions. The number of views (“hits”) of the YouTube videos as well as the number of comments and postings (Facebook OR e-mails) will be recorded. The Facebook Intensity Scale will be used to measure participants’ overall engagement in Facebook for groups E & D only. PGrip-RA program adherence will be monitored as actual use and calculated as a proportion of the number of intervention sessions performed divided by the number of sessions prescribed and recorded in the participants’ online logbooks. Long Term Goal Attainment Scaling, a validated tool, will measure participants’ long term goal attainment levels.
Timepoint [3] 307544 0
At the 3 & 6-month follow-up
Secondary outcome [4] 307545 0
Self-efficacy to improve function related to KTAC Evaluate Outcomes :
The self-efficacy function subscale of the ASES will be used to measure participants’ self-efficacy to improve their functional status. Participants will be asked to rank their self-efficacy to improve their functional capacity.
Timepoint [4] 307545 0
At baseline, 6 weeks immediate post-intervention, 3 months follow-up and 6 months follow-up
Secondary outcome [5] 307546 0
Quality of life (QOL) related to KTAC Evaluate Outcomes :
Quality of life will be assessed using the ‘EuroQoL Index (EQ-5D-5L)’. This generic instrument is the most commonly used and extensively validated measure of health-related quality of life.
Timepoint [5] 307546 0
At baseline, 6 weeks immediate post-intervention, 3 months follow-up and 6 months follow-up
Secondary outcome [6] 307547 0
Usability with online learning related to KTAC Evaluate Outcomes :
Participants in all groups will be assessed according to their level of usability with their respective ICT KT strategy. The System Usability Scale (SUS) instrument, an empirically validated tool will be used to measure participants’ usability perception.
Timepoint [6] 307547 0
At 6 weeks immediate post intervention, 3 months follow-up and 6 months follow-up
Secondary outcome [7] 307548 0
Self-reported pain :
Study participants’ self-reported assessment of pain intensity will be recorded on an online100-mm visual analogue scale (VAS), where 0 represents no pain and 100 mm maximal pain.
Timepoint [7] 307548 0
At 6 weeks immediate post intervention, 3 months follow-up and 6 months follow-up

Eligibility
Key inclusion criteria
In order to be eligible for the study, participants must be as follows: 1) aged between 18-75 years old; 2) have a diagnostic of RA; 3) reside in Canada or Australia;4) without serious co-morbidities chronic disease e.g. cancer or other illness, judged by the patient or study physician to make participation in this study inadvisable;. 5) Medication not expected to change during the study period; 6) self-reported inactivity (30 minutes of moderate physical activity, 5 times or less per week) or not using physical intervention or agents other than prescribed medication, 7) no face-to-face consultation with a health care provider other than general practitioners or rheumatologists for RA in the last 3 months, 8) ability to access the Internet weekly and a functioning e-mail account during the study duration (6 months), and 9) no contra-indications to exercise without supervision established by the revised version of the PA; 10) be able to communicate in English; 11) not have participated in either of the two previous PGrip pilot studies and 12) willingness to sign informed consent.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Not aged between 18-75 years old; 2) Not diagnosed with RA; 3) Reside elswhere than in Canada or Australia;4) With serious co-morbidities chronic disease e.g. cancer or other illness, judged by the patient or study physician to make participation in this study inadvisable;. 5) Medication expected to change during the study period; 6) Self-reported activity (30 minutes of moderate physical activity, 5 times or less per week) or using physical intervention or agents other than prescribed medication, 7) Face-to-face consultation with a health care provider other than general practitioners or rheumatologists for RA in the last 3 months, 8) Not able to access the Internet weekly and a functioning e-mail account during the study duration (6 months), and 9) Any contra-indications to exercise without supervision established by the revised version of the PA; 10) Not able to communicate in English; 11) Have participated in either of the two previous PGrip pilot studies and 12) Nt willing to sign informed consent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The methodology used in the proposed study is in concordance with the-Consort-E-HEALTH guidelines. to randomization, patients will be assessed for eligibility through the use of an admission questionnaire. The admission questionnaire includes demographics, comorbidities, medication intake, years of experience with ICT, expressed preference for ICT and self-reported RA. A logbook, used in previous RCT. will be filled out by each participant as KTAC Monitoring the knowledge using the 7-Day PAR calendar and a bi-weekly questionnaire on potential changes in PA, medication intake, habits and adverse events. In addition to completing the questionnaire, participants will complete an electronic consent form. Participants will be randomly assigned to one of the two Facebook intervention groups (E & D), the PGrip-RA only group, or the control group based on a sequence of computer generated random numbers using a blocking factor (randomly varying block sizes). After the potential participant registers online at [email protected], they will be contacted by the research coordinator and their eligibility will be confirmed with an admission questionnaire, based on our selection criteria, and written informed consent will be via e-mail. If eligible and consenting, the participant will then be randomly allocated to one of the five study groups (A, B, C, D or E), using the central randomization scheme.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly assigned to one of the two Facebook intervention groups (E & D), the PGrip-RA only group, or the control group based on a sequence of computer generated random numbers using a blocking factor (randomly varying block sizes). The research assistant, who is not involved in data collection, will contact the research study Methods Centre data manager. Prior to running the randomization program, the data manager will document the participant’s initial (first and last) and date of birth (month and year) of the participant. After running the program, the data manager will document the intervention assignment with the participant information (initials/DOB), assign a study identification number (ID) and then inform the research assistant of the assignment and participant ID. This process will help ensure concealment of allocation. After randomization, the participant will be informed through e-mail of their group assignment. Participants in the interventions groups (E & D) will receive specific confidential information for log in purposes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
The selected sample size is based on the number of observations needed to estimate the change in self-efficacy to manage pain between baseline and 6 months), the standard deviation of the self-efficacy pain subscale of the ASES for the control group was found to be equal to 1.79. A small to moderate effect size of 0.3 in the self-efficacy pain was identified by the investigators and colleagues as being a minimal clinically important effect size to identify. To detect an effect size of 0.3, the size of the variation in the means as represented by their standard deviation is 0.54, given the common standard deviation within a group measured with the self-efficacy in pain scale of the ASES of 1.79. In a one-way ANOVA study, sample sizes of 32, 32, 32, 32 and 32 are needed for the 5 groups whose means are to be compared. The total sample of 160 subjects achieves 80% power to detect an effect size of 0.3 in the differences among the means versus the alternative of equal means using an F test with a 0.05 significance level. To account for a potential loss to follow-up, the sample size has been adjusted to accommodate a 20% loss which is typical of the losses that we have experienced in similar past studies of this nature; that is, 32/(1-.2)=40 per group, and in total 200.

Data analysis:
Data analysis will be performed using SPSS 21. The analysis will be conducted on an intention-to-treat basis. Descriptive statistics such as proportions means and standard deviation will be used to summarize baseline variables across the five study groups (A to E). Baseline differences among the study groups will be assessed.
For the primary research questions, an analysis of variance (ANOVA) will be conducted to compare groups E, D, C, B and A on the primary outcome self-efficacy to manage pain (ASES) at 6 months follow-up. In particular, Dunnett’s multiparameter test will compare each of Group E, D, C, B to A on the primary outcome. If clinically important differences in baseline variables are found, the interventions will be compared using multiple regression adjusting for these baseline variables and similar multiparameter tests will be conducted.
For the secondary outcomes, self-efficacy to improve function, intention/actual use of self-management strategies, knowledge acquisition, self-reported pain, QOL, and usability of online learning, the same analysis strategy considered for the primary research question will be followed. As well, the change from baseline to 3 months in self-efficacy to manage pain, self-efficacy to improve function, knowledge acquisition, quality of life, and satisfaction with online learning each of these variables will be analyzed in a similar fashion. In order to assess the importance of the different components making up the interventions for Group E, D, C, and B , ANOVA will be conducted and a posterior tests using Tukey’s honestly significance difference will compare Group E to Group D, Group D to Group C, Group C to Group B and Group B to Group A.
In addition, the primary and secondary outcomes will be also compared from baseline to 6 weeks immediate post-intervention, 3 months follow-up as well as to 6 months follow-up, using a 2-way ANOVA with the between factor study groups (Groups A-E) and the within factor time (baseline, 6 weeks, 3 months and 6 months).
The analyses will take place after all study participants have completed the 6 month follow-up.
Exploratory subgroup analyses will be performed by age and sex, and comorbidity.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
Other reasons
This RCT never went ahead. No recruitment was done. We haven't received funding for this RCT and we won't look for funding since the PI is retiring in 2019..
________________________________________
Date of first participant enrolment
Anticipated
1/10/2014
Actual
Date of last participant enrolment
Anticipated
1/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 5940 0
Canada
State/province [1] 5940 0
Across Canada

Funding & Sponsors
Funding source category [1] 288990 0
Self funded/Unfunded
Name [1] 288990 0
Country [1] 288990 0
Primary sponsor type
Individual
Name
Lucie Brosseau
Address
PhD
Full Professor and Epidemiologist University Research Chair
Shool of Rehabilitaton Sciences
University of Ottawa

451 Smyth Road
Room 3060
Ottawa
K1N 6N5
Canada
Country
Canada
Secondary sponsor category [1] 287670 0
Individual
Name [1] 287670 0
Daniel Lefebvre
Address [1] 287670 0
Assistant Director (Grants/Administration) of the Research Management Services

550 Cumberland Street,
Tabaret Hall (159)
Ottawa
K1N 6N5
Canada
Country [1] 287670 0
Canada

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 290799 0
University of Ottawa Ethics Committee
Ethics committee address [1] 290799 0
Ethics committee country [1] 290799 0
Canada
Date submitted for ethics approval [1] 290799 0
01/05/2014
Approval date [1] 290799 0
Ethics approval number [1] 290799 0
H05-06-10B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 14 14 0 0
/AnzctrAttachments/366057-ANZCTR newregisryAppendices-TAS Facebook RCT Mar 2014 GD-1.doc
Attachments [2] 15 15 0 0
/AnzctrAttachments/366057-ANZCTR reference list RCTfacebook.doc
Attachments [3] 27 27 0 0
/AnzctrAttachments/366057(v10-04-2014-00-56-34)-ANZCTR New registry international Facebook RCT Proposal.doc
Attachments [4] 99 99 0 0
/AnzctrAttachments/366057(v18-06-2014-21-57-45)-TIDieR checklist.docx

Contacts
Principal investigator
Name 47286 0
Prof Lucie Brosseau
Address 47286 0
PhD
Full Professor and Epidemiologist University Research Chair
Shool of Rehabilitaton Sciences
University of Ottawa

451 Smyth Road
Room 3060
Ottawa, ON
K1H 8M5
Country 47286 0
Canada
Phone 47286 0
+1 (613) 562-5800 ext. 8015
Fax 47286 0
+1 (613) 562-5428
Email 47286 0
[email protected]
Contact person for public queries
Name 47287 0
Lucie Brosseau
Address 47287 0
PhD
Full Professor and Epidemiologist University Research Chair
Shool of Rehabilitaton Sciences
University of Ottawa

451 Smyth Road
Room 3060
Ottawa, ON
K1H 8M5
Country 47287 0
Canada
Phone 47287 0
+1 (613) 562-5800 ext. 8015
Fax 47287 0
+1 (613) 562-5428
Email 47287 0
[email protected]
Contact person for scientific queries
Name 47288 0
Lucie Brosseau
Address 47288 0
PhD
Full Professor and Epidemiologist University Research Chair
Shool of Rehabilitaton Sciences
University of Ottawa

451 Smyth Road
Room 3060
Ottawa, ON
K1H 8M5
Country 47288 0
Canada
Phone 47288 0
+1 (613) 562-5800 ext. 8015
Fax 47288 0
+1 (613) 562-5428
Email 47288 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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