Background
Methods/Design
Study aim
Study design and setting
Design | Period 1 0–3 months | Period 2 3–6 months | Period 3 6–9 months | Period 4 9–12 months |
---|---|---|---|---|
Sequence ABBA (n = 10) | A = UC | B = MSMP | B = MSMP | A = UC |
Sequence BAAB (n = 10) | B = MSMP | A = UC | A = UC | B = MSMP |
Sequence AABB (n = 10) | A = UC | A = UC | B = MSMP | B = MSMP |
Sequence BBAA (n = 10) | B = MSMP | B = MSMP | A = UC | A = UC |
Study intervention
Usual care period-UC
The multidisciplinary self-care management program period- MSMP
An multidisciplinary self-management program sequence BAAB | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Weeks 1 & 41 | Weeks 3 & 43 | Weeks 5 & 45 | Weeks 7 & 47 | Weeks 9 & 49 | Weeks 11 & 51 | Weeks 12 & 52 | Weeks 13, 27–28, 39–40, 52–54 | Week 52–54 | |||
Assessment and/or Intervention | Medical visit & Screening | Nurse Home Visit | Nurse Teleph. follow-up | Dietician Clinic Visit | Nurse Home Visit | Dietician Clinic Visit | Nurse Telep. Follow-up | Nurse Clinic Visit | Medical Visit nephrologist or diabetologist | End of the study | |
Enrollment | Inclusion/Exclusion criteria | X | |||||||||
Information form | X | ||||||||||
Randomization | X | ||||||||||
Informed consent form | X | ||||||||||
Treatment | 1. Comprehensive initial assessment & evaluation of patients self-care deficits | X | Medical follow-up | ||||||||
Current Medications | X | ||||||||||
Priority setting-one goal & contract signing | X | ||||||||||
2. Teaching & Training on self-care | X | X | |||||||||
Education on DKD | X | ||||||||||
Education on the risk of hypoglycemia | X | ||||||||||
3. Counseling on self-care development | X | X | |||||||||
4. Guiding & support | X | X | X | ||||||||
5. Coordination of Care | X | X | X | X | X | X | X | ||||
6. Follow-up & proactive monitoring | X | X | X | ||||||||
Dietary plan and counseling | X | X | |||||||||
Outcomes’ measurements | Demographics | X | |||||||||
Self-care behavior | X | X | X | ||||||||
Medication adherence | X | X | X | ||||||||
Quality of life | X | X | X | ||||||||
Serum cr, eGFR, urinary albumin/cr ratio | X | X | X | ||||||||
HbA1c | X | X | X | ||||||||
Resource utilization | X | X | X |
The role of the advanced practice nurse- APN
The role of the study diabetologist
The role of the diabetes specialized nurse
The role of the dietician
Identification of eligible patients
Inclusion criteria |
1. Age 18 and over. |
2. Clinical diagnosis of diabetes. |
3. Clinical diagnosis of renal disease and an estimated glomerular filtration rate (eGFR) of less than 60 ml/min calculated based on the CKD Epidemiology Collaboration (CKD_EPI) formula and/or an Albumin/Creatinine ratio of 30 mg/mmol or more. |
4. Free of cognitive deficit as assessed by the recruiting physician, based on a normal score on the French version of the Short Portable Mental Status Questionnaire [45]. In the case of a patient being diagnosed with a cognitive deficit, the physician ensures patient’ referral or follow-up. |
5. Free of psychomotor skills limitations as determined by the recruiting physician based on the physical examination of the patient. |
6. Able to read, write and speak in French. |
7. Signed informed consent. |
Exclusion criteria |
1. Terminal illness other than CKD such as cancer or severe heart failure. |
2. Planned major surgical procedures. |
3. Patient on dialysis. |
4. Patient receiving nursing home care visits for the management of diabetes. |
Randomization
Primary outcome
Secondary outcomes
Dependent variables | Dimension (s) measured | Measure used |
---|---|---|
Patient Variables | ||
Quality of Life | Present Quality of Life | ADDQoL |
Impact of Diabetes on Quality of Life | ADDQoL | |
Impact of Diabetes on Life Domains | ADDQoL | |
Self-Care Behavior | Diet Habits | R-SDSCA |
Exercise Habits | R-SDSCA | |
Blood Sugar Testing | R-SDSCA | |
Foot Care | R-SDSCA | |
Smoking | R-SDSCA | |
Adherence to Antihypertensive Treatment | MEMS | |
Patient Clinical Variables | ||
Blood Glucose control | HbA1c | % |
Kidney Function | Serum Creatinine | μmol/L |
eGFR | ml/min using CKD_EPI | |
Urinary Albumin/Creatinine Ratio | mg/mmol | |
Resource Utilization Variable | ||
The MSMP use outside the defined frequency of the intervention | The number of times the participant seek help from the MSMP outside the defined frequency of the intervention | APN Records Nursing Records Dietary Records |