Integrating nurse-led Self-Management Support (SMS) in routine primary care: design of a hybrid effectiveness-implementation study among type 2 diabetes patients with problems of daily functioning and emotional distress: a study protocol

Table 3 Effect evaluation: outcome measures and time of assessment

Concept	Measurement	Items	Moment in time
Concept	Measurement	Items	3-monthly diabetes consultations during follow-up	T0	T-4	T-12
Primary outcome
Daily functioning	DFT	1		*	*	*
Secondary outcomes
Diabetes-related emotional distress	PAID	20		*	*	*
Mental health problems	PSYCHLOPS	9	*²	*¹	*	*
Mental health problems	4DSQ	50			*	*
Quality of life	SF-12	12		*	*	*
Participation and autonomy	IPA	32 + 9		*	*	*
Job performance	SF-HLQ	5		*	*	*
Self-management knowledge and behaviour	PIH-NL	12		*	*	*
General self-efficacy	GSES-12	12		*	*	*
Control over the disease	Average blood glucose level (HbA1c)	1	*
Health care use		5		*	*	*
Covariates
Patient demographics	Sex	1		*
	Age	1		*
	Year of diagnosis	1		*
	Treatment of diabetes	1		*
	Marital status	1		*
	Education	1		*
Practice nurse demographics	Age	1		*
	Training	1		*
	Type of general practice(s) (one GP, two GPs, group, health centre)	1		*

ISSN: 2731-4553