Couple-based collaborative management model of type 2 diabetes mellitus for community-dwelling older adults in China: protocol for a hybrid type 1 randomized controlled trial

Table 2 Schedule of enrolment, interventions, and assessments

		STUDY PERIOD
	Enrolment	Baseline Assessment	Allocation	Intervention	Follow-up
TIMEPOINT (T for Month)	T₋₂	T₋₁	T₀	T_1–3	At end of T₃	At end of T₆	At end of T₁₂
ENROLMENT:
Eligibility screen	X
Informed consent	X
ALLOCATION			X
INTERVENTION:
Couple-based Intervention Group				X
Individual-based Control Group				X
ASSESSMENTS AND MEASUREMENT:
Baseline socio-demographics: age, gender, marital status, education, retirement status, etc.	X
Mental health: C-MMSE, CES-D		X
*Primary outcomes:*
Blood glucose ^a: HbA_1c		X				X	X
Quality of life: SF-36		X				X	X
*Secondary outcomes:*
Metabolic measures: BP, BMI, WHR, FG & lipid		X					X
Management behaviours ^a: SDSCA		X			X	X	X
Medication adherence ^a: BMQ & medical records		X			X	X	X
Physical activity ^b: IPAQ-C		X			X	X	X
Dietary ^b:FFQ		X				X	X
*Process measures:*
Management efficacy ^b: C-DMSES		X			X	X	X
Dyadic appraisal & coping ^b: Communal coping & support		X			X	X	X

C-MMSE Chinese Mini-Mental State Examination, CES-D the Centre for Epidemiologic Studies Depression Scale, HbA1c hemoglobin A_1c, SF-36 36-item short form survey, BP blood pressure, BMI body mass index, WHR waist hip ratio, FG fasting glucose, SDSCA summary of diabetes self-care activities, BMQ brief medication questionnaire, IPAQ-C International Physical Activity Questionnaire-Chinese, FFQ food frequency questionnaire, C-DMSES the Chinese version of the Diabetes Management Self-efficacy Scale
^a Measure for patients only
^b Repeat measure for spouses of the control arm only at baseline and 12 months

ISSN: 1471-2318