Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change (FEEDBACK): study protocol for a cluster randomised controlled trial

Table 3 Summary of outcome measures and assessment time points

Outcome	Measurement method	Baseline visit		Follow-up (3 months)		Follow-up (6 months)
Outcome	Measurement method	Before visit	After visit	Before visit	After visit	Before visit	After visit
Primary outcome
HbA1c level	Practice records	X				X
Secondary outcomes
*Health-related outcomes*
Probability to achieve the recommended glycaemic target	Practice records					X
CV risk score	Practice records JJ risk engine	X		X		X
HbA1c level	Practice records	X		X
*Behavioural outcomes*
Behavioural management	SDSCA [53, 54]	X		X		X
Prescribed medications	Practice record	X	X		X		X
Psychosocial outcomes
Doctor-patient communication
GP communication	GPAQ [55, 56]		X		X		X
Patient communication self-efficacy	AURA [57, 58]		X		X		X
Participatory decision-making	PACIC [59]	X					X
Psychosocial self-efficacy	ADS [60, 61]	X			X		X
Recall of CV risk score	Open-ended question		X	X
Emotional response to CV risk score	Dedicated Likert scale [62]		X
Perceived credibility of CV risk score	Dedicated Likert scale [63]		X
Intentions to change behaviour	DLBQ [65]	X	X

ISSN: 1745-6215