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. 2019 Aug 6;2019(8):CD012379. doi: 10.1002/14651858.CD012379.pub2

Reese 2017.

Methods

  • Study design: parallel RCT (1:1:1); 376 assessed for eligibility, 120 randomised

  • Study duration: 6 months

  • Study follow‐up: 6 months
Participants

  • Country: USA

  • Setting: community

  • Kidney transplant recipients during the first 2 weeks after transplantation

  • Number (randomised/analysed): intervention group 1 (40/40); intervention group 2 (40/39); control group (40/38)

  • Mean age ± SD (years): intervention group 1 (50 ± 12); intervention group 2 (50 ± 11); control group (49 ± 11)

  • Sex (M/F): intervention group 1 (25/15); intervention group 2 (23/17); control group (24/16)

  • Exclusion criteria: inability to manage medications; poor English comprehension; HIV‐positive serostatus; living more than 120 miles from the centre (because these patients return to local care soon after transplantation); and/or discharge to an acute‐care facility
Interventions

  • Intervention type classification: reminder and reminder plus education

  • eHealth intervention used: blue‐tooth, electronic monitor


Intervention group 1

  • Wireless pill bottle: customised reminder

    • Each participant was provided with a wireless pill bottle (Vitality GlowCap; Vitality Inc) that recorded pill‐cap openings; these data were transmitted in real time to the study database.

    • light on the bottle would illuminate and the cap would chime when the medication was due

    • Adherence data were transferred from the Vitality website to a web‐based secure research platform called Way to Health

    • Participants could select additional reminders, including texts or telephone calls with recorded messages or e‐mails with a weekly adherence summary

    • Each participant could change their intended times of taking medication and/or reminders


Intervention group 2

  • Wireless pill bottle: customised reminder + provider feedback

    • Each participant was provided with a wireless pill bottle (Vitality GlowCap; Vitality Inc) that recorded pill‐cap openings; these data were transmitted in real time to the study database.

    • light on the bottle would illuminate and the cap would chime when the medication was due

    • Adherence data were transferred from the Vitality website to a web‐based secure research platform called Way to Health.

    • Participants could select additional reminders, including texts or telephone calls with recorded messages or e‐mails with a weekly adherence summary.

    • Each participant could change their intended times of taking medication and/or reminders.

    • Every 2 weeks providers received notification if adherence fell below 90%


Control group

  • Received a wireless pill bottle that provided no alerts and only tracked adherence.
Outcomes Primary outcome

  • Adherence (measured by pill bottle electronic records): adherence only measured in the final 90 days of the study (when clinic visits are less frequent)


Secondary outcomes

  • Pill bottle–measured adherence between 14 days and the end of the study;

  • Coefficient of variation of TAC blood concentrations (calculated within each participant)

  • Coefficient of variation of any morning TAC blood concentration, measured for any indication

  • Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS), a validated 5‐item self‐reported questionnaire specific to immunosuppression, administered at study end


Post hoc analysis

  • Compared pill bottle–measured adherence with censoring of data when participants appeared to permanently discontinue pill bottle use

  • Compared adherence in the final 6 weeks

  • Treated days when participants were hospitalised as fully adherent
Notes

  • Funding source: "Leonard Davis Institute (LDI) at the University of Pennsylvania and additional support was provided by the LDI’s Center for Health Incentives and Behavioral Economics"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study described as randomised, method of random sequence generation not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 Blinding of participants High risk Could not have been blinded given the nature of the intervention
Blinding of participants and personnel (performance bias) 
 Blinding of personnel High risk Study coordinator contacted patients if adherence was below 90% in the feedback group, no mention of blinding of study coordinator for participants in other groups
Blinding of outcome assessment (detection bias) 
 Objective outcome Low risk Post hoc analyses were conducted by blinded personnel, no mention of whether this also occurred for primary and secondary outcomes
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Low risk No subjective outcomes were measured
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 3/120 dropped out (2.5%)
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias Unclear risk Insufficient information to permit judgement