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