Skip to content

Effectiveness of an integrated care guideline training programme (Primary Care 101) on the processes and outcomes of non-communicable chronic diseases compared with usual training and support in primary care in South Africa

Effectiveness of an integrated care guideline training programme (Primary Care 101) on the processes and outcomes of non-communicable chronic diseases compared with usual training and support in primary care in South Africa: a pragmatic cluster randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20283604
Enrollment
4598
Registered
2011-03-24
Start date
2011-03-22
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, hypertension, depression, chronic respiratory disease-Primary care management Not Applicable Diabetes, hypertension, depression, chronic respiratory disease-Primary care management

Interventions

Intervention group:Primary care 101 Integrated care guideline 1. Training of existing PALSA PLUS trainers as outreach trainers for expanded guideline (one 5 day training) 2. Outreach training of all

Sponsors

University of Cape Town (South Africa)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Clinics: Nurse-led fixed primary care clinics in the Eden and Overberg districts of the Western Cape province, South Africa (all clinics service around or more than 10,000 attendances per year) 2. Patients -Age more than 18 years and written consent to participate in the study 3. Four cohorts are defined. Patients may fulfill inclusion criteria for more than one cohort. Inclusion criteria based on four target chronic diseases: 3.1. Hypertension: self-reported hypertension on medication 3.2. Diabetes: self-reported diabetes on medication 3.3. Chronic respiratory disease: self-reported asthma/ chronic obstructive pulmonary disease (COPD) / chronic bronchitis/ emphysema or cough and/or difficult breathing for more than 2 weeks (not on TB treatment in the past 3 months) 3.4. Depression: CES-D 10 (Centre for Epidemiologic Studies Depression Scale) score of 10 or more

Exclusion criteria

Exclusion criteria: 1. Clinics: 1.1. Clinics with less than 9,000 attendances in the year preceding randomisation 1.2. Satellite and mobile clinics 1.3. Clinics providing exclusive antiretroviral treatment services 1.4. Clinics where chronic disease care is shared with large referral centres (to limit contamination) 2. Patients: 2.1. Inability to meet the inclusion criteria 2.2. Acute and/or terminal condition precluding participation such as acquired immune deficiency syndrome (AIDS) or cancer 2.3. Psychiatric diagnoses precluding participation such as schizophrenia, dementia and other cognitive impairment measured by self report or medical history 2.4. For chronic respiratory disease: patients receiving TB treatment in the past 3 months will be excluded

Design outcomes

Primary

MeasureTime frame
Based on target chronic condition. 1. Hypertension:Treatment intensification defined as 1.1. Increase in dose of antihypertensive medication or 1.2. Addition of new antihypertensive or 1.3. Addition of aspirin or 1.4. Addition/ increase in dose of statin 2. Diabetes: Treatment intensification defined as 2.1. Increase in dose of oral hypoglycaemic/ insulin or 2.2. Addition of new oral hypoglycaemic / insulin or 2.3. Addition/ increase in dose of angiotensin-converting enzyme (ACE) inhibitor or 2.4. Addition of aspirin or 2.5. Addition/ increase in dose of statin 3. Chronic respiratory disease: Treatment intensification defined as 3.1. Addition of beta-agonist or 3.2. Addition of ipratropium bromide or 3.3. Addition of oral theophylline or 3.4. Addition/ increase in dose of inhaled corticosteroid 4. Depression:Case detection defined as 4.1. Started on antidepressant medication or 4.2. Referred for counselling or 4.3. Referred to psychiatric services All outcomes will be measured 14 months after recruitment (12-14 months after the intervention has started in intervention clinics).

Secondary

MeasureTime frame
Process outcomes 1. Breakdown of treatment intensification and test-ordering outcome by components 2. Appropriate prescribing for cardiovascular disease risk indicated by: 2.1. Proportion receiving aspirin 2.2. Proportion receiving simvastatin 2.3. Proportion receiving ACE inhibitor 3. Appropriate prescribing for obstructive lung disease indicated by: 3.1. Proportion receiving an inhaled corticosteroid 3.2. Ratio of beta-agonist to inhaled corticosteroid 4. Appropriate screening for complications: 4.1. Proportion reporting dilated eye exam 4.2. Proportion reporting foot exam 5. Smoking endpoints: 5.1. Proportion receiving smoking cessation advice 5.2. Proportion who quit 5.3. Number of units smoked per day 5.4. Readiness to quit smoking ( Prochaska and DiClemente model) 6. Proportion of prescriptions filled (as proxy of adherence) Intermediate outcomes 1. Cardiovascular disease risk 2. Systolic BP 3. HbA1C 10. Waist circumference 11. Body mass index (BMI) Health outcomes 1. Cardiovascular (CVS) event (acute myocardial infarction (MI) and/or stroke and/or death) 2. Mortality 3. HRQoL (EuroQol 5D, St Georges Respiratory Questionnaire, CESD-10) Economic 1. WHO?s Disability Assessment Schedule II 2. Income and changes due to illness 3. Admissions 4. Inpatient days 5. Clinic visits All outcomes will be measured 14 months after recruitment (12-14 months after the intervention has started in intervention clinics).

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026