Contributions to the literature
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Self-management is crucial to chronic disease management, but the adoption and adherence of self-management is generally poor among older patients.
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Our study explores how to incorporate older couples’ routine interactions into the disease management regime, and to build a collaborative management model with professional medical supervision and couple’s mutual support.
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This collaborative model provides innovative solutions for improving and maintaining older patients’ self-management behaviors; and facilitates the implementation of primary prevention for their informal carers mainly spouses at risk.
Background
Gaps in chronic disease management for older patients
Significance of spouse in chronic disease management
Theoretical basis for CCMM
Previous research on CCMM
Methods
Study design
Setting
Participants
Recruitment
Sample size
Randomization and allocation concealment
Procedures
Module | Dosage & Delivery | Components | Couple-based Intervention Group | Individual-based Control Group | BCT a |
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Health Education & Training | 4 weekly 2-h sessions, delivered by two care managers in class. | Group Education | T2DM patients & their spouses | T2DM patients | Comparison of behavior |
1. Diabetes & Complication | |||||
Understand diabetes Hypoglycemia Glucose monitoring | Couple-level discussion & practice | Patient-level discussion & practice | Shaping knowledge | ||
2. Healthy Diet | |||||
Diabetes nutrition Food label Dietary plan | Collaborative- management Collective behavior goal setting | Self-management Individual behavior goal setting | Social support b Goals & planning | ||
3. Medication | |||||
Taking (multi-) medication Medication adherence Foot care | Couples identify barriers & solutions collaboratively; | Patients identify barriers & solutions themselves; | Antecedents Association | ||
4. Being Active | |||||
Exercise recommendations Risk management Exercise goal & plan | Use “we will” in these activities. | Use “I will” in these activities. | Goals & planning | ||
Behavior Change Booster | 2 months of weekly tailored call | Interactive call tailored to participant’s behavior change barriers, with call frequency varied by their progress. | Deliver to the couple | Deliver to the patient only | Repetition & substitution Feedback & monitoring |
Behavior Change Incentive | Throughout intervention | Vouchers gain or lose by fulfilling or failing management tasks, with group ranking. | Incentives for individual & couple performance | Incentives for individual performance only | Reward & threat |
Interventions
The individual-based education & training
The couple-based education & training
Behavior change booster
Behavior change incentives
Intervention fidelity
Study measures
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 |
Primary outcomes
Secondary outcomes
Process measures
Statistical considerations
Implementation evaluation
Domain | Indicators | Source | Data Collection Tool |
---|---|---|---|
Reach | Participation rate | Participants & Disease management system | Enrolled couples /all couples being contacted |
Representativeness | Enrolled couples / all eligible couples registered in the system | ||
Effectiveness | Health outcomes | Participants | HbA1c, Quality of life, BMI, WC, blood pressure, fasting glucose & lipid profile; management and healthy behaviors (exercise, diet) |
Adoption | Number of health workers who prefer couple-based over individual-based interventions | Community health workers | Qualitative interview and survey of community health workers |
Implementation | Treatment fidelity | Randomly selected taped sessions | 10% of taped sessions randomly selected and reviewed by an expert panel, against the full detailed intervention manuals for adherence and quality. |
Participant involvement | Participants | Course registration forms recording attendance rate | |
Participant satisfaction | Participants | Satisfaction questionnaire on the program, from 1 (strongly disagree) to 4 (strongly agree). | |
Incremental cost- effectiveness ratio (ICER) of the intervention and control arms | Participants | ICER = ∆C/∆E = (Cintervention − Ccontrol)/ (Eintervention – Econtrol); C is the program and labor costs; E is effectiveness defined as the percentage of patients whose HbA1c is lower than 7% | |
Maintenance | Effectiveness over 1 year | Participants | Same as effectiveness. |