OPAM-IA: Using Digital Activity Trackers to Improve Physi... | NCT02554474

NCT02554474

Status Module

Sponsor/Collaborators Module

Name	Class
Simon Fraser University	OTHER
Arthritis Research Centre of Canada	OTHER
Vancouver General Hospital	OTHER
The Arthritis Society, Canada

Oversight Module

Description Module

Detailed Description

Patient self-management is a fundamental component in arthritis care that is often neglected. Physical activity is an essential part of self-management, however, less than half of people with arthritis are active. There are several factors that are associated with low physical activity participation such as motivation, doubts about the effectiveness of prescribed exercises, and lack of health professional advice on ways to progress physical activity. The variety of risk factors highlights the need for a multifaceted approach that provides support in terms of knowledge, skill development and timely advice from health professionals, as well as motivational support to stay active.

Our primary objective is to assess the efficacy of a physical activity counselling model, involving the use of a Fitbit Flex (wireless physical activity tracker) paired with a FitViz application (app), a group education session, and telephone counselling by a physiotherapist, to improve physical activity participation in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Our secondary objective is to assess the effect of the intervention on reducing patients' sedentary time, and improving fatigue, mood, pain, and self-efficacy in arthritis management. We will carry out three aims: 1) To develop the FitViz app to pair with Fitbit to enhance user experience, 2) To conduct a pilot test for the Fitbit/FitViz intervention, 3) To evaluate the effect of the physical activity coaching model in patients with RA and SLE. In this proof-of-concept randomized controlled trial (RCT), the investigators hypothesize that compared to a control group (i.e. the Delayed Intervention group), participants in the Immediate Intervention Group will 1) increase moderate/vigorous physical activity (MVPA), 2) reduce sedentary time, 3) improve in fatigue, mood, and pain levels, and 4) improve in their self-efficacy in disease management.

The investigators will use a mixed-methods approach, involving a RCT and in-depth interviews. The proof-of-concept study will employ a stepped wedge RCT design, whereby the intervention will be sequentially rolled out to participants over a number of time periods. The order in which individuals receive the intervention will be determined at random. The strength of this design is that it can properly address the efficacy question, while avoiding the dilemma of withholding the intervention to some participants, as in a parallel group design.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate Group	Active Comparator	Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as >= 10 consecutive minutes or more at the level of >= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.	Behavioral: Education, Fitbit/FitViz, physiotherapist counselling.
Delay Group	Placebo Comparator	Time spent in sedentary activity was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours.	Behavioral: Same intervention with a 9-week delay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Education, Fitbit/FitViz, physiotherapist counselling.	Behavioral	Participants will receive a brief education session, use a physical activity tracker Fitbit Flex with paired with a FitViz app, and remote counseling by a PT. Intervention will be received immediately.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Daily Time in Moderate/Vigorous Physical Activity	Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as >= 10 consecutive minutes or more at the level of >= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.	Baseline, 9 weeks, 18 weeks, 27 weeks

Secondary Outcomes

Measure	Description	Time Frame
Time Spent in Sedentary Activity	Time spent in sedentary activity was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours.	Baseline, 9 weeks, 18 weeks, 27 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Linda Li, PhD	Professor	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arthritis Research Canada		Richmond	British Columbia	V6X 2C7	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30886950	Background	Li LC, Feehan LM, Shaw C, Xie H, Sayre EC, Avina-Zubeita A, Grewal N, Townsend AF, Gromala D, Noonan G, Backman CL. A technology-enabled Counselling program versus a delayed treatment control to support physical activity participation in people with inflammatory arthritis: study protocol for the OPAM-IA randomized controlled trial. BMC Rheumatol. 2017 Nov 28;1:6. doi: 10.1186/s41927-017-0005-4. eCollection 2017.
32248626

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components will be delivered to the participants in Months 1 and 2. The session will include a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants will use the Fitbit/FitViz. The PT will review the progress with participants via bi-weekly phone calls and progressively modify their activities. In Month 3-6, participants will continue using the Fitbit/FitViz and have access to a PT via email as needed, but no bi-weekly phone calls. Education, Fitbit/FitViz, physiotherapist counselling.: Participants will receive a brief education session, use a physical activity tracker Fitbit Flex with paired with a FitViz app, and remote counseling by a PT. Intervention will be received immediately.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 9, 2017

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
BG001	Delay Group	Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00059 BG00159 BG002118

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline

- ParticipantsOG00059
- ParticipantsOG00159

Title	Measurements
	OG00037.8± 39.6

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	We performed an intent-to-treat analysis. For the main comparison, we used analysis of covariance (ANCOVA) to estimate an adjusted mean difference comparing time in MVPA at 9 weeks (primary end point) between groups, adjusting for baseline MVPA, diagnosis, and blocking.					Adjusted difference in mean change	9.4			2-Sided	95	-0.5	19.3					Superiority

Secondary

Time Spent in Sedentary Activity

Time spent in sedentary activity was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours.

Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.

Posted

Mean

Standard Deviation

Minutes

Baseline, 9 weeks, 18 weeks, 27 weeks

ID	Title	Description
OG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
OG001	Delay Group

Secondary

Fatigue Severity Scale

The Fatigue Severity Scale consists of 9 questions and measures the impact of fatigue. A total score is calculated by averaging the rating from each question. Range 1-7; lower score = less fatigue.

Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 9 weeks, 18 weeks, 27 weeks

ID	Title	Description
OG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
OG001	Delay Group	Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.

Secondary

McGill Pain Questionnaire Short Form (MPQ-SF)

The MPQ-SF contains 15 pain-related words, which can be rated from 0 to 3. Range 0 - 45; higher=more severe pain.

Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 9 weeks, 18 weeks, 27 weeks

ID	Title	Description
OG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
OG001	Delay Group	Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.

Secondary

The Patient Health Questionnaire-9 (PHQ-9)

The PHQ-9 consists of nine questions (rated from 0 to 3) that correspond to nine diagnostic criteria for major depressive disorder. Range 0-27; lower score = less depressive symptoms),

Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 9 weeks, 18 weeks, 27 weeks

ID	Title	Description
OG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
OG001	Delay Group	Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.

Secondary

Partners In Health Scale

The Partners in Health Scale is a 12-item measure designed to assess self-efficacy, knowledge of health conditions and treatment, and self-management behaviors such as adopting a healthy lifestyle. Range 0-96; higher score = higher perceived confidence and ability in self-care.

Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 9 weeks, 18 weeks, 27 weeks

ID	Title	Description
OG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
OG001	Delay Group

Secondary

The Self-Reported Habit Index (SRHI) - Sitting at Work Index

The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of habit of sitting at work. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.

Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 9 weeks, 18 weeks, 27 weeks

ID	Title	Description
OG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
OG001

Secondary

The Self-Reported Habit Index (SRHI) - Sitting at Leisure Index

The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of habit of sitting at leisure. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.

Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 9 weeks, 18 weeks, 27 weeks

ID	Title	Description
OG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
OG001

Secondary

The Self-Reported Habit Index (SRHI) - Walking Index

The SRHI is a 12-item scale, rated on a 7-point Likert scale, that measures characteristics of habitual behavior. Participants rated their strength of walking habit. A higher score indicates a stronger habit or behavior that is done frequently, automatically, and done without thinking about it. Range 1-7; higher score = stronger habit.

Week 27: Immediate Group - 1 additional participants withdrew, Delay Group - no additional participant withdrew; 6 with missing data.

Posted

Mean

Standard Deviation

score on a scale

Baseline, 9 weeks, 18 weeks, 27 weeks

ID	Title	Description
OG000	Immediate Group	Education, Fitbit/FitViz, physiotherapist counselling. These 3 components were delivered to the participants in Weeks 1-8. The session included a short presentation about physical activity in everyday life, an individual goal-setting session with a registered PT, and an orientation to the Fitbit and FitViz app. Participants used a Fitbit and the FitViz app. The PT reviewed the progress with participants via bi-weekly counselling phone calls and progressively modify their activities. In Weeks 9-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.
OG001	Delay Group

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Immediate Group	Time spent in Moderate/Vigorous Physical Activity (MVPA) was measured with a SenseWear Mini sensor over a 7-day period. The mean time was calculated in bouted MVPA per day. A bout is defined as >= 10 consecutive minutes or more at the level of >= 3 METs (i.e., the lower bound of MVPA), with allowance for interruption of up to two minutes below the threshold.	0	59	0	59	13	59
EG001	Delay Group	Time spent in sedentary activity was measured with a SenseWear Mini sensor over a 7-day period. The mean daily time spent in sedentary activity was calculated with an energy expenditure of <=1.5 METs, occurring in bouts of >= 20 minutes during waking hours.	0	59	0	59	10	59

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Muscle pain	Musculoskeletal and connective tissue disorders		Non-systematic Assessment		EG00010 affected59 at risk EG0019 affected59 at risk
Ligament sprain	Musculoskeletal and connective tissue disorders		Non-systematic Assessment		EG0003 affected59 at risk EG0011 affected59 at risk

A limitation is the inclusion of only individuals with rheumatoid arthritis and systemic lupus erythematosus. We focused on these 2 diseases because of feasibility for recruitment in our community. The findings, however, are not generalizable to people with other types of inflammatory arthritis. Furthermore, the results may not be generalizable to men because 89% of the participants were women.

Certain Agreements

ID	Term
D007592	Joint Diseases
D001172	Arthritis, Rheumatoid
D008180	Lupus Erythematosus, Systemic
D009043	Motor Activity
D001168	Arthritis

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D001519	Behavior

ID	Term
D004522	Educational Status

Same intervention (Education, Fitbit/FitViz, physiotherapist counselling) with a 9-week delay. The full intervention was delivered in Week 10-17. In Weeks 18-26, participants continued using the Fitbit and FitViz and had access to a PT via email as needed, but no bi-weekly phone calls.

ID	Term
D012959	Socioeconomic Factors
D011154	Population Characteristics