Methods

Location: United States and Puerto Rico

Design: randomised controlled trial

Unit of allocation: individual

Start date: December 2011

End date: January 2013

Duration of intervention: 12 months

Time points measured: baseline, 4 months, and 12 months (only baseline and 4 months reported in this article. Moy 2016 reports 12‐month data)

Participants

Population description: Participants were identified from the Veterans Association (VA) national database of patients with COPD who received care within the year before enrolment from a primary care provider, cardiologist, or pulmonologist within the VA healthcare system. All participants were over 40 years of age and had access to a computer with Internet access, used email regularly, were able to walk 1 block, and had received medical clearance from a doctor

Setting: own home

Method of recruitment: a random subset of 29,000 veterans (half urban and half rural) sent an email invitation

Total number randomised: 238 participants were randomised in a 2:1 ratio to intervention (n = 154) or control (n = 84) groups

Participants: 238, 223 were male with only 15 female participants. This is unusual but was not unexpected given that the target population consisted of veterans

Age: average age, 67 years

Interventions

The intervention comprised online and wearable technology. Participants were instructed to wear a pedometer daily and to upload step‐count data regularly. Each participant had a weekly goal that was based on:

• average of most recent 7‐day step counts + additional 600 steps;

• previous goal + 600 steps; or

• 10,000 steps/d

Participants had Web access to step‐count feedback, allowing self‐monitoring; weekly goal setting, educational/motivational content and an online community forum. Valid wear days were those on which at least 100 steps and 8 hours of step counts were recorded

Outcomes

Self‐reported health‐related quality of life (SGRQ) and daily step counts (pedometer) were reported at 4 months and at 12 months. Hospitalisations and acute exacerbations were reported at 12 months only

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Interested participants completed an online questionnaire that assessed inclusion criteria, after which a computer algorithm determined eligibility and participants were randomized in a 2:1 ratio to intervention or control groups (p 129)

Allocation concealment (selection bias)

Low risk

Allocation was done by computer, and both groups received a pedometer; therefore, group allocation was unclear to all participants (p 135)

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Blinding was not possible; therefore, although limited as all study activity was online, participants may have been influenced by prior beliefs about whether or note the intervention is likely to work. Group allocation was revealed online (p 130). Also, participants were required to upload step‐count data weekly, which may have introduced bias

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No blinding of outcome assessment; therefore, participants may have given what was perceived as the 'right' response. However, this may have been limited by lack of direct contact with researchers and other participants, as questionnaires were completed by participants online (p 129)

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Reasons for missing outcome data not reported (p 130)

Selective reporting (reporting bias)

Low risk

Both groups reported but third time point measured at 12 months not reported; email correspondence with study authors indicates that paper reporting results at 12 months has been prepared for publication

Other bias

Low risk

Study appears to be free from other sources of bias

Methods

Location: Twente, Netherlands

Design: randomised controlled trial

Unit of allocation: individual

Start date: October 2010

End date: April 2011

Duration of intervention: 4 weeks

Time points measured: baseline, end of week 1, follow‐up measurement end of weeks 2, 3, 4

Participants

Population description: participants with a clinical diagnosis of COPD and no infection/exacerbation for 4 weeks before measurement. All were current/former smokers, had Internet access, and could read/speak Dutch. Participants were excluded if they had impaired hand function causing inability to use the application or any illness that influenced daily activities, other respiratory diseases, needed regular oxygen therapy, and received training with a physiotherapist during the 6 weeks before starting the study

Setting: own home

Method of recruitment: recruited by chest physician or nurse practitioner

Participants: 30 (14 to intervention group and 16 to control group)

Age: average 66 years

Interventions

Intervention is an app comprising 2 modules

• Activity coach

• Web portal for recording symptoms and activity levels

Daily completion of the diary on the Web portal triggered a decision support system in cases of exacerbation. The activity coach consisted of a 3‐D accelerometer and smart phone with bluetooth. Both were worn by the participant

Outcomes

Self‐reported health status using the CCQ and mean activity level (pedometer)

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Eligible participants were randomly assigned to intervention or control group according to a computer‐generated randomisation list (programme: Block Stratified Randomization V5: Steven Piantadosi) whereby blocked randomisation was applied in blocks of 4, stratified for gender (p 3)

Allocation concealment (selection bias)

Low risk

Participants and investigators enrolling participants could not foresee assignment because allocation to groups was conducted by a different person from the one who conducted the randomisation, recruited participants, and collected data (p 3)

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Blinding was not possible; therefore, although potentially limited as all study activity was online, participants may have been influenced by prior beliefs about whether or not the intervention is likely to work. Allocation procedure not described (p 3)

Blinding of outcome assessment (detection bias)
All outcomes

High risk

No blinding of outcome assessment occurred; therefore, participants may have given what was perceived as the 'right' response (p 3)

Incomplete outcome data (attrition bias)
All outcomes

Low risk

All data accounted for in Figure 1 (p 5). One participant in the intervention group was lost to follow‐up owing to technical problems. No participants were lost from the control group

Selective reporting (reporting bias)

Low risk

Data on all outcomes, at all collection points, between groups, and within groups were reported (Tables 2, 3, 4) (p 6)

Other bias

Low risk

Study appears to be free from other sources of bias

Methods

Location: Maastricht, Netherlands

Design: randomised controlled trial

Unit of allocation: individual

Start date: May 2012

End date: July 2013

Duration of intervention: 6 months

Time points measured: baseline and 6 months

Participants

Population description: Participants from 5 general practices and from a Dutch online panel were recruited. Participants who had a diagnosis of COPD or were at moderate/high risk of COPD were eligible to participate. They were also required to have access to the Internet at home, to be between 40 and 70 years of age, and to speak Dutch proficiently

Setting: own home

Method of recruitment: some recruited by email (Dutch online panel) and some by postal mail (6 general practices)

Participants: 1325 (662 participants in the intervention group and 663 in the control group). 627 were men and 698 were women. Those with a diagnosis of COPD totalled 284, with 146 in the experimental group and 138 in the control group

Age: average age 58 years

Interventions

The intervention is an app called 'MasterYourBreath', which was designed to change health behaviour through a Web‐based app providing computer‐generated individualised feedback. It included 2 behaviour change modules ‐ smoking cessation and physical activity ‐ with 6 intervention components: health risk appraisal, motivational beliefs, social influence, goal setting and action plans, self‐efficacy, and maintenance. Participants could switch modules and choose to enter 1 or more of the 6 intervention components per module intervention components if they wished. Participants accessed the app through a personalised account and used it ad libitum for 6 months

Outcomes

Primary: smoking cessation and physical activity

Secondary: health status measured using the CCQ, intention to change behaviour, and secondary smoking cessation measures

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

A permuted block design with a random block size varying from 4 to 20 was used to randomise participants, who were stratified by channel of recruitment (p 1063)

Allocation concealment (selection bias)

Unclear risk

A researcher who was not involved in data collection or analysis performed randomisation and allocation revealed online for the main group; it is not clear how allocation was revealed for the practice group. It was not feasible to blind participants to group assignments owing to the study design (p 1063)

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Blinding was not feasible; participants may have been influenced by prior beliefs about whether or not the intervention is likely to work (p 1064)

Blinding of outcome assessment (detection bias)
All outcomes

High risk

Outcome assessment was conducted by a self‐administered Web‐based questionnaire at baseline and at 6 months for all participants. No blinding of outcome assessment occurred; therefore, participants may have given what was perceived as the 'right' response

Incomplete outcome data (attrition bias)
All outcomes

High risk

All incomplete and complete data are reported (p 1067 and Table 2)

Selective reporting (reporting bias)

Low risk

Data on all outcomes, all collection points, between and within groups are reported in Table 4. Findings of subgroup analysis on participants with a diagnosis of COPD were also reported but were not presented. Researchers provided raw data for this subgroup for inclusion in the meta‐analysis for this review

Other bias

Low risk

Other sources of bias are not evident