Structured Diabetes Education Program for Improving Self-care Behavior in Primary Care Settings of Puducherry: Evidence from a Randomized Controlled Trial.

CONTEXT: Diabetes self-management education plays a critical role in improving patients' clinical outcome and quality of life. AIMS: This study aims to study the effectiveness of a structured diabetes educational program on improvement of self-care behavior among type 2 diabetics in urban Primary Health Centres (PHCs) of Puducherry. SETTINGS AND
DESIGN: A community-based open-label parallel-arm randomized controlled trial was conducted in two randomly selected urban PHCs of Puducherry during December 2015-February 2017. SUBJECTS AND METHODS: Using systematic random sampling, 157 eligible participants were recruited in intervention and control PHCs each. Sociodemographic, disease characteristics, and anthropometric measures were captured using a pretested questionnaire at baseline. Self-care behavior was recorded with Summary of Diabetes Self-Care Activities scale. Intervention consisted of structured diabetes education sessions with distribution of information leaflets and self-care kits to the intervention-arm participants, while control arm received standard care. At the end of 6 months, endline assessment was done for both groups. Data were analyzed by intention-to-treat, per-protocol, and difference-in-difference analysis using STATA.
RESULTS: Footcare increased significantly by 1.95 days/week compared to control arm, while a moderate change of 0.49 days/week in diet compliance and a minimal change of 0.10 days/week in physical activity were observed. Medication adherence, regular blood sugar testing, and smoking behavior also showed improvement in intervention arm.
CONCLUSIONS: A structured education program that is culturally tailored showed an overall improvement in self-care behavior. This research supports the need for structured education program for diabetics to empower them and improve self-care practices. TRIAL REGISTRATION: CTRI/2017/06/008772.

INTRODUCTION

Diabetes management requires a multipronged approach as the patients’ activities in day-to-day life have a strong influence on their outcomes, well-being, and quality of life. Poor awareness about self-care practices influences the disease progression and the complications arising in patients with diabetes.[1] Self-care practices can be systematically taught to diabetics with a planned diabetes self-management education (DSME).[2] DSME standards define quality DSME and assist diabetes educators to provide cultural and age-appropriate evidence-based education. In developing countries like India with limited resources and increasing treatment costs for diabetes, the self-care component may lead to better economic and therapeutic outcomes.[3] There is paucity of DSME programs in India despite the vital need and growing disease burden. Hence, this intervention study was planned to study the effectiveness of a structured diabetes educational program on improvement of self-care behavior among type 2 diabetes patients in urban Primary Health Centres (PHCs) of Puducherry.

SUBJECTS AND METHODS

This study was a community-based open-label parallel-arm randomized controlled trial done in Puducherry during December 2015–February 2017. The study was approved by Institute Ethics Committee, permitted by Directorate of Medical Services, Puducherry and registered with Central Trial Registry of India (CTRI/2017/06/008772).

Adult patients (aged 18 or more) with type 2 diabetes, residing in the PHC service area and receiving treatment from chronic disease clinic at urban PHCs were included in the study.

Sample size was calculated based on the expected difference between two groups in mean change in the Summary of Diabetes Self-Care Activities (SDSCA) score at the end of the intervention. To detect a mean change of 0.6 days/week in the footcare SDSCA score,[4] assuming dropout rate of 15%, the minimum sample size required was 152/arm based on 90% power and 5% significance level using OpenEpi version 3 Software (Emory University, Atlanta, USA).

Two PHCs (Kosapalayam PHC and Mudaliarpet PHC) were randomly chosen (by lot) out of 12 urban PHCs of Puducherry district and were allocated to intervention and control arm, respectively, by flipping coin method. Recruitment of patients was done by systematic random sampling method; every fifth patient from the registration list during the noncommunicable disease (NCD) clinic days till required sample size was reached in each of the PHCs.

A data collection pro forma was designed to collect details on sociodemographic characteristics, disease, and treatment details. Self-care activities were measured using the revised SDSCA questionnaire.[5] The score consists of the number of days per week, on a scale of 0–7, on which the respondent has engaged in self-care activities during the previous week. Higher score suggests better self-management in the particular domain. The questionnaire was pretested among ten diabetic patients attending NCD clinic of JIPMER rural health centre. The questionnaire was translated from English to Tamil and backtranslated to English by two independent persons well versed in English and Tamil.

After obtaining a written informed consent from the participants, data on sociodemographic characteristics, disease condition, and treatment details were collected. A baseline assessment of self-care practices was done using SDSCA. Details related to disease, comorbidities and treatment, and recent blood sugar levels were extracted from the health records. Height and weight were recorded, body mass index was calculated, and blood pressure (BP) in sitting posture was measured.

Operational definitions used in the study were as follows: “Current tobacco or alcohol use” – A person who has used tobacco in any form/any quantity of alcohol at least once in the last 1 month at the time of the interview; ”Regular Blood sugar testing” – a person getting blood sugar checked as prescribed by physician or at least once in 3 months; ”Poor glycaemic control” – diabetic patient with last blood glucose monitored showing fasting blood sugar >125 mg/dl or “Postprandial Blood Sugar or Random Blood Sugar” >180 mg/dl; “Compliance to self-care” – a person performing a specific self-care activity for >3 days in a week.

The intervention and education materials were developed in collaboration with a diabetes specialist, a community physician, two nurses, medical social worker, and two dieticians and based on guidelines by the Indian council of medical research, American Diabetes Association, and the American Association of Diabetes Educators (AADE). Flipchart and information cards were prepared in English and then translated into Tamil. Self-care kits consisting of a mirror, an oil bottle, and glucose tablets were provided to each participant to create interest on self-care activities.

In the intervention arm, individuals were divided into small groups to conduct the education sessions in the Anganwadis nearest to the participants’ residences (eight sessions with around 20 participants each). The structured diabetes education program was delivered by the primary investigator in two sections of 45 min focusing on AADE's seven areas of diabetes self-care – “healthy eating, being active, regular blood-sugar monitoring, taking medication on time, problem-solving, reducing risks and healthy coping.” Footcare was taught by demonstration, and participants were asked to give reverse demonstration to ensure comprehension.

Individuals were followed up for a period of 6 months. A brief reinforcement session was conducted at the same Anganwadis at the end of 3rd month of follow-up for sharing of experiences by the participants. At the end of 6 months, endline assessment was done, and individuals who could not be contacted on more than two attempts were included in loss to follow-up. At the control PHC, standard care for diabetes without any self-care intervention continued for 6 months after baseline assessment. At the end of the intervention, the education program was conducted for individuals in the control arm, and self-care kits were distributed.

Data were single entered using EpiData software version 3.1 (EpiData Association, Denmark) and analyzed using STATA statistical software version 11 (StataCorp, Texas, USA). Continuous variables such as age and BP were expressed as mean (standard deviation [SD]), and categorical variables were expressed as proportions. Self-care behavior score for dietary, exercise, and footcare was measured as number of days in the past week the particular activity was performed. Summary SDSCA scores were calculated for each domain of self-care by calculating the sum of days of items in each domain divided by number of items in the domain. Difference in difference analysis was done to compare mean changes in each of the above behaviors before and after intervention across the groups with 95% confidence intervals (CIs) reported. Both intention-to-treat and per-protocol analysis were done for change in self-care behaviors in SDSCA. For participants “Lost to follow up,” “last observation carried forward method” was used.

RESULTS

Figure 1 depicts participant recruitment and follow-up details. The characteristics of loss to follow-up individuals (11 participants) were similar to the sample population. Mean age of participants was 53 (SD 10) and 56 (SD 11) years in intervention and control groups, respectively. Both the groups were comparable in terms of sociodemographic and disease characteristics [Table 1].

Figure 1

Flowchart depicting the participant recruitment and follow-up details. *Death due to cardiovascular event (unrelated to the trial)

Table 1

Sociodemographic characteristics in the two groups at baseline (n=314)

Study characteristics	Intervention group (n=157), n (%)	Control group (n=157), n (%)
Age >40 years	139 (88.5)	143 (91.1)
Female gender	94 (60.0)	108 (68.8)
Education
No formal education or primary	46 (29.5)	73 (46.5)
Middle school or above	111 (70.5)	84 (53.5)
Socioeconomic status*
Class I and II	37 (23.6)	32 (20.4)
Class III	79 (50.3)	73 (46.5)
Class IV and V	41 (26.1)	52 (33.1)
Disease duration ≥5 years	103 (65.6)	98 (62.4)
Presence of comorbidity
Hypertension	61 (38.6)	65 (41.4)
Heart disease	05 (03.2)	06 (03.8)
Neuropathy	63 (40.1)	70 (44.6)
Foot complications	17 (11.3)	42 (26.8)
Obesity (BMI ≥25)	95 (60.2)	97 (61.3)
Poor glycemic control	71 (44.6)	70 (45.2)
Treatment
Only OHA (not insulin)	137 (87.3)	136 (86.6)
Behavioral risk factors
Current tobacco users	31 (20.3)	20 (12.7)
Current alcohol users	16 (10.1)	12 (7.6)

*Modified BG Prasad’s scale, June 2016. OHA: Oral hypoglycemic drugs

Table 2 shows mean difference in dietary, physical activity, and footcare behaviors at the end of the intervention period according to intention-to-treat analysis. Figure 2 shows SDSCA summary scores at the end of the intervention.

Table 2

Change in summary of diabetes self-care activities score in the three domains of self-care at the end of intervention between the two groups (intention-to-treat analysis)

Dietary SDSCA In the last 7 days	Intervention group (n=157), mean			Control group (n=157), mean			Mean difference (95% CI)	P
	Baseline	Endline	Difference	Baseline	Endline	Difference
Dietary domain
Follow a healthful eating plan	3.80	4.39	0.59	3.08	3.18	0.10	0.49 (0.2-0.8)	0.001
Follow eating plan over past month	3.79	4.34	0.55	2.81	3.04	0.23	0.32 (0.01-0.6)	0.04
Consume ≥5 servings of fruits and vegetables	0.03	0.08	0.05	0.06	0.09	0.03	0.02 (−0.01-0.1)	0.3
Eat high fat foods (meat/full-fat dairy products)	0.77	0.76	−0.01	0.82	0.77	−0.05	−0.04 (−0.05-0.1)	0.3
Space carbohydrates throughout day	0.65	0.93	0.28	0.37	0.39	0.02	0.26 (0.1-0.4)	0.007
Physical activity domain
Participate in 30 min of physical activity	3.83	4.05	0.22	3.64	3.76	0.12	0.10 (−0.1-0.3)	0.3
Participate in specific exercise session	2.66	2.97	0.31	1.82	1.95	0.13	0.18 (−0.01-0.4)	0.09
Footcare domain
Check your feet	1.87	3.64	1.77	2.39	2.21	−0.18	1.95 (1.4-2.4)	<0.001
Inspect the inside of your footwear	0.52	1.34	0.82	1.22	1.26	0.04	0.78 (0.5-1.0)	<0.001
Wash your feet	6.80	6.84	0.04	5.89	5.96	0.07	−0.03 (−0.04-0.1)	0.5
Soak your feet	0.22	0.11	−0.11	0.29	0.35	0.06	−0.16 (−0.3-0.04)	0.01
Dry between your toes after washing	3.13	3.91	0.78	3.36	3.48	0.12	0.66 (0.3-1.0)	<0.001

SDSCA: Summary of diabetes self-care activities, CI: Confidence interval

Figure 2

Change in summary of diabetes self-care activities summary scores at the end of intervention between the two groups, n = 314

Compliance to self-care showed a statistically significant additional improvement of 33.5% (95% CI 22.9–44.0) in checking the feet before and after intervention. An improvement of 11.8% (95% CI 6.6–16.9), 8.4% (95% CI 2.5–14.2), and 8.7% (95% CI 2.9–14.2) in inspecting the footwear, drying between the toes, and following a healthful eating plan was observed, respectively.

Additional increase of 2% was observed in participants taking medication regularly and checking blood sugar level regularly in the intervention arm. None of the participants quit smoking after the intervention; but a decrease of around 4% (95% CI [15.0] to 7.2) was seen in individuals smoking more than three cigarettes in intervention arm when compared with control arm. The results obtained in per-protocol analysis were similar to the results of intention-to-treat analysis for all the variables.

DISCUSSION

This study showed significant additional improvement in various footcare domain activities and moderate change in dietary domain in the intervention arm compared to control arm. Regarding diet, our study showed an additional improvement of 0.21 days/week in diet SDSCA summary score in the intervention group that was statistically significant. This is similar to the intervention in China[6] which showed an increase of 0.34 days/week in the intervention arm following an education program of 6 weeks. In our study, improvement in dietary aspect was found mostly in practices which were perceived as feasible and affordable. Marginal improvement of 0.26 days/week was seen in the even spacing of carbohydrates, as working participants or homemakers may not be able to comply with scheduled timings for small and frequent meals. Similarly, consumption of high fat foods such as chicken, mutton, and high fat dairy products was already less prevalent at baseline, and hence, scope for improvement was minimal. Five or more servings of fruits and vegetables per day were followed by very few participants as affordability was a major issue. Moreover, success of intervention is believed to increase by involving the caretaker in the dietary counseling process as elderly depend on their sons and daughter-in-law or other caretakers for diet.[7] Revision in government food procurement, pricing, and marketing policies for sustained availability and affordability of cheaper dietary substitutes in the market may improve feasibility in this domain.[8]

In the physical activity domain, the baseline mean scores were 3.8 days/week with compliance of 57% in the intervention arm of our study. SDSCA scores were found to vary from 1 to 4.2 days/week of physical activity in studies from other countries[910] while studies from India indicate 10% to 52% of diabetics doing regular physical activity.[11] Our study found additional improvement of 0.2 days/week in SDSCA mean score of intervention arm participants. Such small improvements (0.3–0.9 days/week) have been documented in literature even with intense behavioral support (telephone self-management). Some studies have shown improvement of 3.58 days/week owing to continuous individualized reinforcement and weekly counseling strategies compared to one-time reinforcement in our study. Environment also plays a role in physical activity behavior; hot and humid climate, overcrowded neighborhood, and the absence of footpath in urban Pondicherry may be other barriers.

In this study, baseline mean score was 1.8 days/week for checking the feet against 5.5 days/week from other countries.[912] Recent studies from India showed compliance levels of 8% to 45% in checking feet.[111314] At the end of the intervention, an additional improvement of 1.95 days/week in SDSCA mean score and 33.5% increase in compliance for checking of feet was observed in intervention group compared to control group. This concurs with previous studies from Pondicherry (increase of 2.1 days/week)[15] and Iran (improvement of 2.9 days/week).[16]

Behavior change which requires minimal additional effort or has least deviation from routine is the most easily accepted ones. Footcare behavior such as regular washing and cleaning of feet are part of our culture which makes this behavior acceptable for the participants; it neither involves extra cost nor much time. In addition, use of a simple self-care kit at the household level for activities such as moisturizing and daily inspection of feet empowers the patients. This self-care behavior if sustainable has a scope for minimizing high occurrence of foot-related complications in our setting.

As both the study groups showed good compliance to medication at baseline (95%–98%), there was little scope for improvement. Similarly, blood sugar monitoring showed a minimal additional improvement of 2% postintervention. This behavior is limited by health system functioning in terms of available resources and physician prescription behavior. Marginal improvement was seen in terms of reduction in smoking behavior in our study. To be effective, smoking cessation requires behavioral support to boost motivation and pharmacotherapy based on nicotine dependence; one-time counseling provided in this study was not sufficient.

This intervention study was among one of the firsts to be conducted in primary care settings. Intervention package was developed based on standard guidelines and with consideration of local practices. The self-care kit acted as a tool of interest and participant motivation. Use of Anganwadis as venue for health education sessions made it convenient for the participants. Standardized tools enabling comparison across studies, validated data entry, and robust statistical methods were used. Minimal participants (3.5%) were lost to follow-up during the study. Delivery of intervention under normal conditions makes it generalizable to majority of diabetics in primary care setting.

This study has proven that a structured diabetes education program in a primary health care setting can serve as an effective vehicle to improve self-care practices that are feasible and when awareness was lacking. However, dietary and physical activity domains that require additional resources, time, and effort need to be addressed through other strategies, and further research is recommended for planning feasible and effective interventions. Intervention module developed in this study can be utilized by health care workers as a standard health education practice. However, one-time education program for newly diagnosed diabetics has not shown any sustained difference in lifestyle.[17] Therefore, it is essential to conduct such programs at diagnosis and during regular clinic visits to sustain self-care skills in disease management. Health educator's role in such sessions can be taken up by a nurse, social worker, or other health workers with support of physician. Anganwadis and other community groups can also be utilized to disseminate and sustain diabetic self-care practices in the community.

CONCLUSIONS

The structured education program intervention showed significant changes in footcare and dietary domains of self-care behavior among type 2 diabetes patients in urban primary care setting of Puducherry. This research supports the need for such programs in integration within primary care settings to improve glycemic control and decrease complication profile by empowering the patients and improving self-care practices.

Financial support and sponsorship

This study was financially supported by JIPMER intramural fund.

Conflicts of interest

There are no conflicts of interest.