Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT04819256
Eligibility Criteria:
Inclusion Criteria:
* Living within the designated geographical zone
* 50 years and above
* Satisfy the Medical Criteria below:
1. Diabetes with HbA1c ≥ 9% (within past 6 months), and
2. At least 1 complication
1. chronic kidney impairment stage 3 and above, or diabetes overt nephropathy,
2. ischaemic heart disease, or congestive cardiac failure,
3. peripheral arterial disease, or diabetes foot/ diabetes foot-related complications,
4. diabetic retinopathy/ treatment for retinopathy, and
5. stroke, or transient ischaemic attack
* Satisfy at least 2 conditions in the psycho-social, functional or activation domain of which 1 criteria must be from the psycho-social domain:
1. Psycho-social issues
a. Lack of care giver support i. No care-giver (when indicated) ii. Care-giver skills gap/ stress iii. Inability of copy when patient is the care-giver b. Difficult relationships (family/ workplace/ social network) c. Social isolation/ lack of social connectivity i. Lives alone ii. Lack of social network support d. Financial i. Financial difficulty/ insecurity ii. Housing/ shelter issues iii. Poor money management
2. Functional
1. Clinical Frailty Score ≥ 4, requiring help in instrumental activities of daily living (iADL)
2. Requires assistance in ADL or iADL
3. Activation a. Lack of ability to manage health - disengaged or overwhelmed i. Anxiety or disease-related distress ii. Confusion or lack of understanding of care plans iii. Non-adherence to medications/ follow up
* Patient gives consent to participate
* For patients who may be seeing a Primary Care Physician (PCP) outside of the polyclinic for chronic disease management and where the PCP has indicated consent to co-manage the patient with the PACE-It team including the polyclinic physician
* Patient must be willing to receive care in the polyclinic
Exclusion Criteria:
* Patients who are on follow up with Primary Care Physicians or General Practitioners elsewhere for management of their chronic conditions and they do not consent to co-managing patient with the PACE-It team
* Patients who have severe cognitive impairment, depression or psychiatric conditions that interfere with the ability to engage with the healthcare team
* Patients who are (i) not community ambulant or (ii) bed bound
* Patients with terminal illness
* Patients who have are in other programs or research studies
* Patients who do not give consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04819256
Study Brief:
Protocol Section:
NCT04819256