Table 2.
Summary of individual trials, by intervention strategy.
| Source (clusters marked) | Population (adult unless otherwise specified) | Location(s) and time of study | Intervention details & sample demographics | Comparison group & sample demographics | Outcome measure(s) | Effect size & time scale |
|---|---|---|---|---|---|---|
| Patient education–by pharmacists | ||||||
| Grover et al. (44) | Children aged 7-12 years old with asthma along with their parents | Delhi July–December 2012 | Educational programme - presentation, workbook and activities delivered by 2 pharmacists. 24 pairs of parent and child Mean age: 10.2 67% Male | Usual care 16 pairs of parent and child Mean age: 10.4 63% Male | BMQ Questionnaire Asthma control score via asthma control questionnaire | Mean BMQ score improved from 1.5 to 0.26 in the intervention group vs. no change from 1.4 in the control group after 6 months. Significant improvement in asthma control score (p < 0.001) in intervention vs. baseline after 6 months |
| Srirama et al. (65) | T2DM | Tamil Nadu (Coimbatore) May 2009-December 2009 | Pharmaceutical care by pharmacist including medication counseling and leaflets 60 subjects Mean age: 53.4 50% Male | Usual care 60 subjects Mean age: 58.0 50% Male | HbA1c, FBG, quality of life | Significant Improvement in HbA1c, quality of life and FBG in intervention after 8 months (p < 0.01) vs. no significant change in control after 8 months |
| Renuga et al. (59) | T2DM | South India Timeframe not stated | Continuous counseling at baseline,1,2 and at 3 months follow-up (30 min per session) by clinical pharmacists with provision of patient education leaflets 200 subjects Mean Age: 57.8 22% Male | Counseling at baseline and at 3 months follow-up and provided patient education leaflets 200 subjects Mean Age: 57.6 11% Male | MAQ questionnaire FBS | Significant improvement in mean adherence in both groups after 3 months (p < 0.001) & Increase in adherence score was significantly higher in intervention than control group (p < 0.001) at 3 months Significant reduction in mean fasting blood sugar in both groups but statistically significantly higher in intervention group (p < 0.001) at 3 months |
| Simon et al. (57) | T2DM | Multicentre (specific locations not specified) Trial registered February 2019. Timeframe not stated | Pharmacist led verbal counseling including adherence (20 min, single session) with patient information leaflet 46 subjects Mean Age: 56.8 54% Male | Usual care 47 subjects Mean Age: 56.8 63.8% Male | MARS questionnaire HbA1c | Significant Improvement in adherence in intervention vs. control (p < 0.001) at 6 months Significant improvement in HbA1c (p < 0.001) in intervention vs. control at 6 months |
| Sundarajan et al. (54) | Post-MI | Tamil Nadu November 2017-April 2018 | Pharmacist education including adherence (30 min, single session). Patient information leaflets were explained and provided during discharge 75 subjects Mean Age: 56.3 76% Male | Usual care 75 subjects Mean Age: 53.9 86.7% Male | MARS questionnaire Clinical parameters e.g., BP, FBS and total cholesterol | Significant improvement in medication adherence (p = 0.0001) at 6 months Significant improvement in clinical parameters e.g., SBP, DBP, FBS, total cholesterol (p = 0.003,p = 0.007,p = 0.04,p < 0.001 respectively) in intervention vs. control at 6 months |
| Sathvik et al. (48) | Hypertension | Karnataka Timeframe not stated | Pharmacist education regarding prescribed medications at baseline, 15th, 30th and 45th day 75 subjects 17.3% aged 41–50 40% aged 51–60 18.7% aged 61–70 53.3% Male | Usual care 75 subjects 20% aged 41–50 36% aged 51–60 25.3% aged 61–70 41.3% Male | BMQ questionnaire (broken down by belief, recall, access and regimen scores) | Significant improvement in, belief (p = 0.03) and recall (p = 0.05) BMQ scores of intervention vs. control at 2 months follow-up but no significant difference in regimen and access scores. |
| Ponnusankar et al. (45) | Chronic conditions like hypertension, T2DM, CVD, and asthma | South India Timeframe not stated | Pharmacist-led counseling on disease, medication and dosage (single session) 30 subjects 6.7% aged ≤ 40 66.% aged 41–60 26.6% aged ≥61 63.3% Male | Usual care 60 subjects 8.3% aged ≤ 40 63.3% aged 41–60 28.3% aged ≥61 51.7% male | Pill count method to calculate percentage compliance Self-assessment form | Intervention group adherence was 92.24 vs. 84.71% in the control group at 2 months follow-up. 75% of patients in intervention rated themselves as always compliant vs. 66.6% in the control group |
| Patient education–by CHW | ||||||
| Gamage et al. (63) Cluster | Hypertension | 3 Regions - Kerala (Trivandrum region), Andhra Pradesh (Rishi Valley and Western Godavari) November 2015-September 2016 (different start dates in different regions) | CHWs monitored BP, provided education about hypertension including importance of adherence to medication every 2 weeks for 3 months 637 subjects Mean age: 56.6 41.3% Male | Usual care 1097 subjects Mean age: 56.9 42.1% Male | Use of antihypertensive medication via interview Control of hypertension (number with BP < 140/90mmHg) | No effect seen with intervention Significant increase in hypertension control in intervention vs. control (p = 0.001) after 3 months |
| Pradeep et al. (49) Cluster | Women with Major Depressive Disorder | Rural Bangalore August 2006–September 2009 | CHWs visited patients providing education and encouraging treatment adherence (visits occurred twice a month). CHWs also visited patients who discontinued medication 138 women 26.8% 26–35 27.5% aged 36–45 26.1% aged 46–55 0% Male | Usual care where patient was encouraged by physician during follow-up consultations 122 women 24.6% aged 26–35 35.2% aged 36–45 24.6% aged 46–55 0% Male | Total number of weeks taking antidepressants Hamilton depression rating scale | Weeks of treatment adherence was significantly greater in intervention vs. control group (p < 0.01) at 6 months No significant difference in severity of depression or QoL between intervention and control group although both groups improved compared to baseline at 6 months |
| Joshi et al. (61) Cluster | Intermediate-to-high risk of CVD | 3 rural regions, not specified August 2011-February 2012 | CHWs monitored risk factors, ascertained and reinforced adherence during 6 household visits over 12 months, every 2 months 1650 subjects Mean age: 61.7 % Male not given | Usual care 1611 subjects Mean age: 61.7 % Male not given | Proportion of consumed and prescribed number of pills SBP | Adherence to antihypertensive drugs was significantly greater in intervention vs. control (p = 0.001) at 12 months. No significant difference between SBP at 12 months (p = 0.18) though both groups saw a significant reduction compared to baseline (p < 0.01) |
| Xavier et al. (64) | Acute coronary syndrome | New Delhi, Jaipur, Lucknow, Bhopal, Nagpur, Wardha, Hyderabad, Secunderabad, Pune, Shivamogga, Bangalore, Chennai, Coimbatore, Kottayam August 2011–June 2012 | CHWs delivered 6 sessions where discussed strategies for adherence, assessed and reinforced the need for adherence and discussed lifestyle measures (4 visits in hospitals - at discharge and in outpatient clinics, 2 home visits over one year) 404 subjects Mean age: 55.9 82% Male | Usual care 401 subjects Mean age: 56.9 83% Male | Composite medication adherence scale (≥80% score counted as adherent) Change in BP, BMI, HR, cholesterol | Significantly increased adherence in the intervention group vs. control (p = 0.006) after 1 year Significantly lower SBP (p = 0.002) and BMI (p < 0.0001) in intervention vs. control. No significant change in HR, DBP or cholesterol after 1 year. |
| Patient Education - by multidisciplinary team | ||||||
| Sadeghian et al. (58) | T2DM | Delhi March 2010-May 2013 | Educational self management programme by a multidisciplinary medical team. Group education. 2x2hr sessions in small groups including information on taking medication. 134 subjects 29.6% aged ≤ 40 39.5% aged 41–50 30.9% aged 51–60 42.1% Male | Routine treatment 123 subjects 20.1% aged ≤ 40 42.2% aged 41–50 37.5% aged 51–60 36.4% Male | HbA1c | Significantly greater fall in HbA1c in intervention vs. control (p = 0.001) after 6 months. |
| Training Practitioners | ||||||
| Sylaja et al. (46) Cluster | Stroke / TIA survivors | Kerala (Thiruvananthapuram) December 2017-December 2018 | Formal training programme for Community Health Workers including importance of educating on medication adherence. 114 subjects Mean age: 59.8 69.3% Male | Community health workers who did not receive additional training. 120 subjects Mean age: 59.4 71.7% Male | Number of patients advised to adhere to medications Control of hypertension (systolic BP) and diabetes (FBS) | Significant increase in intervention vs. control (p < 0.001) at 6 months No significant differences at 6 months |
| Combining education from non-physicians with regular follow-up | ||||||
| Abdulsalim et al. (56)* | COPD | Manipal Recruitment March 2012-June 2013 & 2 years follow-up | Pharmacist education (single session, 15–20 minutes) placing emphasis on adherence, smoking cessation, exercise, inhaler use and need for timely follow-up (n = 130). Further follow-up by monthly phone calls ensuring adherence. Patient information leaflets provided. 104 subjects Mean age: 60.6 96.9% Male | Usual care 98 subjects Mean age: 61.1 94.4% Male | MAQ questionnaire | Significant improvement in medication adherence in intervention vs. control at all follow-up time points up to 2 years (p < 0.001) |
| Suhaj et al. (62)* | COPD | Manipal Patients screened March 2012-June 2013 and f | Clinical pharmacist led counseling (one-on-one, 15–20 minutes) and patient information leaflets. Patients received monthly telephones for medication adherence. During follow-up (every 6 months) patients were provided further motivation for adherence. 104 subjects Mean age: 60.6 96.9% Male | Usual care with 6 months follow-up. 98 patients Mean age: 61.1 94.4% Male | Health-related quality of life (HrQOL) via St. George's Respiratory Questionnaire | Significant improvement in intervention vs. control (p < 0.001) after 2 years |
| Raj et al. (60) | NCDs among (age > 60) including T2DM, hypertension, dyslipidemia and coronary artery disease among | Karnataka (Bangalore) January 2016 to December 2017 | Education and tailored advice delivered by trial investigators, medication diary and telephone reminders. 25 subjects Mean age: 69.1 48% male | Usual Care 25 subjects Mean age: 69.2 60% male | Change in reported pill counts Clinical parameters–BP, blood glucose and serum lipids | Significantly improved reported pill counts in intervention vs. control at 3 months (p = 0.007) and 6 months (p = 0.003) No significant differences between intervention and control |
| Sheilini et al. (52) | Hypertension | Manipal July 2013 to February 2017 | Nurse led individualized teaching session with information leaflets, focussing on medication adherence. Combined with weekly medication-reminder boxes and telephone reminder for follow-up 80 subjects 42.1% aged 60 to 70 17.8% aged >70 42.2% male | Usual care 80 subjects 38.8% aged 60 to 70 19.4% aged >70 53.3% male | MAS Change in SBP and DBP | Significant improvement in medication adherence in intervention vs. control group (p < 0.001)at 6 months No improvement in SBP or DBP in intervention vs. control (p > 0.05) at 6 months |
| Technology based interventions | ||||||
| Kleinman et al. (47) | T2DM | Ahmedabad, Mumbai, Chennai March 2015 to January 2016 | Mobile Health: diabetes management smartphone app and Web portal 44 subjects Mean age: 48.8 81.8% male | Usual care 47 subjects Mean age: 48 58.7% male | Self-reported medication adherence HbA1c | Significant improvement of medication adherence in intervention vs. control (p = 0.03) after 6 months Significant improvement of HbA1c in intervention vs. control (p = 0.02) after 6 months |
| Shetty et al. (51) | T2DM | Chennai Time of study not stated | Text messages to reinforce adherence every 3 days to follow dietary modification regime, physical activity, and drug schedules 110 subjects Mean age: 50.1 % male not reported | Usual care 105 subjects Mean age: 50.5 % male not reported | Validated questionnaire to assess adherence. BMI, Fasting plasma glucose, HbA1c, total cholesterol, LDL | Drug prescriptions were followed satisfactorily by both intervention and control groups. Significant decrease in fasting plasma glucose (p < 0.002) and LDL (p < 0.02) in intervention vs. control at 1 year. No significant difference in HbA1c, BMI or total cholesterol |
| Fixed dose combinations | ||||||
| Thom et al. (50) | CVD or at risk of CVD | Bikaner, Delhi, Lucknow, Ludhiana, Jaipur, Chandigarh, Trivandrum, Hyderabad, Chennai, Pune, Mysore, Mumbai (July 2010 to July 2012) | Fixed-dose combination-based strategy 501 subjects Mean age: 62.1 81.5% male Demographic data for subjects in India not reported, overall data (India & Europe) provided | Usual care 499 subjects Mean age: 61.6 82.3% male Demographic data for subjects in India not reported, overall data (India & Europe) provided | Self-reported medication adherence Change in systolic BP and LDL | Significantly improved adherence in intervention vs. control (p < 0.001) at 15 months Significantly reduced SBP and LDL in intervention vs. control (p < 0.001) at 15 months |
| Valsaraj et al. (53) | Chronic Kidney Disease undergoing dialysis | Karnataka January 2013 to February 2014 | Cognitive Behavioral Therapy (10 individual 50 minute sessions on weekly basis delivered by trained therapist) 33 subjects 67% aged 43 to 65 70% male | Non directive counseling on importance of adherence, with same number/ duration of sessions 34 subjects 66% aged 43 to 65 71% male | Haemodialyssi adherence scale including drug adherence subscale based on questionnaire Change in systolic BP, diastolic BP, Hb and inter-dialysis weight gain | Drug adherence score significantly increased in intervention vs. control (p = 0.001) after 6 months Significant decrease in systolic BP (p = 0.001) diastolic BP (p = 0.001) and inter-dialysis weight gain (p = 0.001), and significant increase in Hb (p = 0.001) in intervention vs. control after 6 months. |
| Pillai et al. (55) Cluster | Depression | Goa April 2007 to September 2009 | Collaborative stepped care management model including psychoeducation, interpersonal psychotherapy, and collaborative case management 1360 subjects 20.4% aged 30–39 26.2% aged 40–49 23.8% 60 years and over 17.6% male Demographic data not split for intervention and control | Enhanced usual care (treatments of choice could be initiated) 1436 subjects 20.4% aged 30–39 26.2% aged 40–49, 23.8% 60 years and over, 17.6% male Demographic data not split for intervention and control | Self-report of antidepressant adherence for 1 month of those who received an antidepressant prescription | 66.8% adherent with intervention vs. 31% in usual care (OR 6.10) After 1 month Significantly higher proportion with intervention completed at least 90 days of treatment vs. usual care P values not stated |
BP; blood pressure; BMI, body mass index; CHW, community health worker; CVD, cardiovascular disease; BMQ, brief medication questionnaire; DBP, diastolic blood pressure; FBS, fasting blood sugar; HR, heart rate; LDL, low density lipoprotein; MARS, medication adherence rating scale; MAQ, Morisky Adherence Questionnaire; MI, myocardial infarction; SBP, systolic blood pressure; T2DM, type 2 diabetes mellitus. *trials based on same original data set. Average age given where possible–otherwise percentage of patients in up to three age bands reported.