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. 2020 Mar 30;20:123. doi: 10.1186/s12877-020-01528-5

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 T1–3 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: HbA1c 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 A1c, 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