In recent years, great emphasis has been placed on the role of nonpharmacological self-management in the care of patients with diabetes. Studies have reported that nurses, compared to other healthcare professionals, are more likely to promote preventive healthcare seeking behaviors. The aim of this study was to investigate the effectiveness of a nurse-led diabetes self-management education on glycosylated hemoglobin. A two-arm parallel-group randomized controlled trial with the blinded outcome assessors was designed. One hundred forty-two adults with type 2 diabetes were randomized to receive either usual diabetes care (control group) or usual care plus a nurse-led diabetes self-management education (intervention group). Duration of the intervention was 12 weeks. The primary outcome was glycosylated hemoglobin (HbA1c values). Secondary outcomes were changes in blood pressure, body weight, lipid profiles, self-efficacy (efficacy expectation and outcome expectation), self-management behaviors, quality of life, social support, and depression. Outcome measures were assessed at baseline and at 12-week and 24-week postrandomizations. Patients in the intervention group showed significant improvement in HbA1c, blood pressure, body weight, efficacy expectation, outcome expectation, and diabetes self-management behaviors. The beneficial effect of a nurse-led intervention continued to accrue beyond the end of the trial resulting in sustained improvements in clinical, lifestyle, and psychosocial outcomes. This trial is registered with
Iran is located in western Asia covering a total land area of 1,648,195 km2. By 2014, with a population of 82,801,633, Iran became the 16th most populous country in the world [
Different members of the healthcare team can provide diabetes self-management education. Much of research comparing the effectiveness of discipline-based education has not determined clear differences in the quality of services delivered by different healthcare professions [
This study took place in an urban primary and secondary outpatient endocrine clinic located within a teaching hospital in Ilam city, Iran. The hospital has a daily outpatient diabetes clinic with a daily turnover of approximately 20–30 patients except on Friday [
The trial was conducted as a single-center, observer-blinded, parallel group (2 groups) randomized controlled trial.
Eligible participants were randomized into two groups:
The control group receives usual diabetes care routines. The intervention group receives usual diabetes care plus 24 weeks of the nurse-led DSME intervention.
Participants were eligible if they were Iranian adults aged ≥18 years, who were clinically diagnosed with T2DM for at least 6 months, and had the medical record showing HbA1c ≥ 8%. To make sure that the lack of access to healthcare does not pose significant barriers to diabetes self-management, all patients were recommended to participate in follow-up at regular intervals. We required patients to participate in follow-up care (at least two visits per year) and have no evidence of a serious medical illness.
Exclusion criteria include cognitive dysfunction, pregnancy, uncontrolled high blood pressure (≥180/110 mmHg), hearing impairment, vision impairment, hemolytic anemias, and hemoglobinopathies. Patients were excluded if they were illiterate, had acute or chronic diabetes complications, and had major difficulties in activities of daily living.
The recruitment process was conducted in two stages. The first stage involved strategies to ensure adequate participant enrolment via placing an advertisement on the message boards of the clinic.
The second stage involved screening and assessment process by evaluating previous medical histories, measurement of HbA1c values, blood pressure, and visual acuity, and completion of three validated questionnaires regarding cognitive function (modified Mini-Mental State Examination (3MS)) [
In this study, we had multiple outcome variables, and the mean values were used for further analysis. Estimated sample sizes for each outcome variable were calculated independently, and the largest of the sample sizes was chosen as the target sample size. The following formula was used to calculate the sample size (Lemeshow et al., 1990: cited in [
To detect the difference in means of outcomes, a minimum of 71 patients were needed for each arm (accounting for 20% loss to follow-up) [
The usual diabetes care is based on the Iranian Ministry of Health Guideline on the management of the T2DM, which involves self-care management, lifestyle modification, and medication adherence. Individual-based education was provided at three monthly intervals with the duration of 20–30 minutes per appointment. Face to face consultations and pamphlets are used to provide the usual diabetes care education. Physical examination and laboratory tests are performed at each visit in accordance with national guidelines. Based on the physical examination and laboratory findings, prescription refills or renewal are obtained during the check-ups.
In addition to usual diabetes care, participants in the intervention group received a 12-week nurse-led DSME founded in the theoretical framework from Albert Bandura’s self-efficacy theory [
Participants in the intervention group received (1) a detailed information booklet, which includes information on conducting self-management, (2) viewed four 10-minute movie clips, (3) attended four weekly group-based educational sessions, and (4) received follow-up telephone calls weekly.
A multidisciplinary team including endocrinologists, nutritionists, nurses, and pharmacists, with the actual intervention to be carried out by a nurse, designed the intervention program. The pilot version of the intervention was then produced and validated by fourteen patients with T2DM.
The booklet consisted of six sections: (1) diet, (2) physical activity, (3) medication, (4) monitoring of blood glucose, (5) foot care, and (6) healthy living with diabetes. The booklet was developed based on the two sources of self-efficacy, that is, verbal persuasion and performance accomplishment. Participants in the intervention group received the booklet at the start of the program. The content of the booklet was used throughout the entire length of the intervention to direct further learning, elaboration, and discussion or to create resources for self-directed learning.
For the first 4 weeks of the intervention, participants were invited to watch four 10-minute weekly movies. The movie is based on the content of the booklet. The language used in the movies was Persian. They were designed and developed by the research team to provide coaching and encouragement (verbal persuasion). Based on the educational contents, four movies were produced in different field of diabetes self-management including general information about T2DM, preventing short- and long-term complications (session 1), physical activity, daily foot care (session 2), healthy eating (session 3), and healthy living with diabetes (session 4).
Four group discussion sessions were carried out at weekly intervals, but the scheduling was flexible and the seating was limited to 10 participants for each session. These sessions were carried out weekly during the first 4 weeks of the intervention. Each session lasted for 120 minutes. The focus of these sessions was on building knowledge, self-efficacy, and skills regarding self-goal setting, action plan, problem-solving, sharing, and peer support. The group discussion sessions were facilitated by the first author (GA), who is a diabetes specialist nurse with 4 years of clinical experience. Participants’ family members were encouraged to attend sessions that can provide multibeneficial support for the patient and their families. All group members were heartened to actively participate in each session. Group members who miss a session received a follow-up from the facilitator before the next session. Standard guidelines were developed for the group discussions and used in all the sessions held. At the last meeting of the group session, all group members received a list of residential phone numbers and were encouraged to ask for help if needed.
Two months after the end of the group discussion sessions, intervention participants received a phone call once per week. Each follow-up call lasted approximately 15–20 minutes. The purpose of the telephone calls was to foster continued performance accomplishment via positive verbal persuasion. Telephone calls were based on principles of motivational interviewing (MI) that successfully help patients to engage and support them in making better health choices [
A single laboratory analyzed all blood samples. For the blood tests, 10 cc of fasting venous blood was taken after fasting for at least 8–10 hours.
Whole blood levels of HbA1c, total triglyceride, total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) were measured. NycoCard HbA1c analyzer (made in the US) was used for quantitative determination of HbA1c value. Lipid profile tests were conducted using an Auto Analyzer BT-3000 (made in Spain).
Blood pressure was measured as the mean of two measurements performed after 5 min of rest while patients were seated with a cuff placed on their dominant arm at the same vertical height as the heart, using an automated blood pressure monitor (UA-779, A&D Instruments Ltd., Abingdon, UK). Weight and height were measured using a weighing and height scale (BT-ETS002, Medical Hospital Electronic height scale with weight measure, China). The participant’s weight and height were measured without shoes or heavy clothing according to a standardized procedure. Patients were asked to stand up as straight as possible and look straight ahead. Body mass index (BMI) was calculated with the formula
Efficacy expectation (self-efficacy) was measured using the Diabetes Management Self-Efficacy Scale (DMSES) [
Outcome expectation was measured using the Perceived Therapeutic Efficacy Scale (PTES) [
Diabetes self-management behavior was measured using the validated Diabetes Self-Management Questionnaire (DSMQ). The instrument was translated from English into Persian in accordance with a recommended translation procedure [
The quality of life was measured using the World Health Organization Quality of Life Scale (WHOQOL-BREF). The WHOQOL-BREF is a self-administered, abbreviated version of the WHOQOL-100 containing 26 items divided into four domains and two general items. The WHOQOL-BREF scores were transformed on a scale from 0 to 100 with the higher scores indicating better quality of life [
Social support was measured with the Medical Outcome Study (MOS) Social Support Survey (SSS) tool. The MOS is a 19-item self-report instrument, measuring a multidimensional of the functional aspects of perceived social support, developed for patients with chronic conditions [
Depression was assessed using the Centre for Epidemiology Studies Short Depression Scale (CES-D) [
All data were analyzed using SPSS software (version 22, IBM Company, Chicago, IL, USA). Statistical significance was reported at the 0.05 alpha level, with two-tailed
Ethical approval was granted from the University Putra Malaysia Ethics Committee for Research Involving Human Subjects and Medical University of Ilam Ethics Committee. Patients were informed about the purpose of the study and gave their consent prior to participation.
Between October 2016 and Jun 2017, 348 patients were approached and invited to participate in this study. Eighty-three patients did not meet the study inclusion criteria, and 78 declined to participate. The main reasons for declining participation were time constraints and family obligation. Of the 187 eligible patients, 13 did not respond (either telephone contact was not achieved after 6 repeated attempts or wrong phone number), 12 agreed to attend but did not, 11 not interested after reading the information, 7 responded after the deadline, and 2 not willing to be randomized. In total, 142 eligible patients were randomized; 72 were allocated to the intervention group and 72 were allocated to the control group.
During the 24-week follow-up period, 6 patients dropped out (4.2%), of whom 5 had been allocated to the control group and 1 to the intervention group (Figure
Consort flow diagram of study participation.
Mean age at baseline was 54.2 ± 11.8 years (range 22–69 years), and two-thirds of the participants were female (65.5%). Majority of the participants had primary education (45.1%), and nearly three-fifths of them (58.5%) were currently working. A vast majority of participants had middle socioeconomic status; only 4.9% reported having difficulties meeting basic needs. Approximately three-quarters of the participants (76.1%) never smoked. The mean duration of diabetes was 8.9 ± 7.4 years. Participants were characterized by poor glycemic and blood pressure control. 58.5% had HbA1c ≥ 9%, and 9.1% had blood pressure at the recommended target < 130/80 mmHg. The proportion of self-blood glucose monitoring was similar for those who conducted it and those who did not, at 50% (see Table
Sociodemographic characteristics of study participants.
Characteristics | Total sample |
Intervention group |
Control group |
---|---|---|---|
Age, yearsa | 56 ± 11.1 | 55.09 ± 10.16 | 53.49 ± 10.98 |
Genderb | |||
(i) Male | 49 (34%) | 23 (32.4%) | 26 (36.6%) |
(ii) Female | 93 (65.5%) | 48 (67.6%) | 45 (63.4%) |
Marital statusb | |||
(i) Married | 117 (82.4%) | 58 (81.7%) | 59 (83.1%) |
(ii) Single (divorced/widow) | 25 (17.6%) | 13 (18.3%) | 12 (16.9%) |
Educational statusb | |||
(i) Primary education | 64 (45.1%) | 33 (46.5%) | 31 (43.7%) |
(ii) Secondary education | 23 (16.2%) | 12 (16.9%) | 11 (15.5%) |
(iii) Tertiary education | 55 (38.7%) | 26 (36.6%) | 29 (40.8%) |
Occupation statusb | |||
(i) Working | 83 (58.5%) | 28 (39.4%) | 31 (43.7%) |
(ii) Not working | 59 (41.5%) | 43 (60.6%) | 40 (56.3%) |
Difficulty paying for basicsb | |||
(i) Very hard | 7 (4.9%) | 5 (7%) | 2 (2.8%) |
(ii) Somewhat hard | 96 (67.6%) | 47 (66.2%) | 49 (69%) |
(iii) Not hard at all | 39 (27.5%) | 19 (26.8%) | 20 (28.2%) |
Smoking statusb | |||
(i) Current smoker | 18 (12.7%) | 9 (12.7%) | 9 (12.7%) |
(ii) Never | 108 (76.1%) | 55 (77.5%) | 53 (74.6%) |
(iii) Ex-smoker | 16 (11.3%) | 7 (9.9%) | 9 (12.7%) |
Duration of diabetes, yearsa | 8.9 ± 7.4 | 8.8 ± 7.5 | 9.04 ± 7.31 |
Presence of at least one comorbidityb | 113 (79.5%) | 57 (80.3%) | 56 (78.9%) |
Use of SBGMa | 71 (50%) | 32 (45.1%) | 39 (54.9%) |
BMI (kg/m2)a | 28.78 ± 3.34 | 28.69 ± 3.25 | 28.87 ± 3.46 |
Systolic blood pressure (mmHg)a | 132.3 ± 11.2 | 130.6 ± 9.6 | 133.9 ± 12.4 |
Diastolic blood pressure (mmHg)a | 86.6 ± 5.9 | 85.8 ± 5.2 | 87.3 ± 6.4 |
HbA1ca | 9.32 ± 1.11 | 9.32 ± 1.06 | 9.31 ± 1.15 |
(i) 8–8.9%b | 59 (41.5%) | 29 (40.8%) | 30 (42.3%) |
(ii) ≥9%b | 83 (58.5%) | 42 (59.2%) | 41 (57.7%) |
Triglyceridea | 142.4 ± 34.9 | 142.83 ± 34.4 | 142.09 ± 35.7 |
Total cholesterola | 172.5 ± 46.8 | 173.14 ± 45.4 | 171.91 ± 48.4 |
HDLa | 53.44 ± 12.62 | 53.68 ± 12.8 | 53.21 ± 12.4 |
LDLa | 94.28 ± 27.86 | 95.89 ± 30 | 92.68 ± 25.6 |
Note: aMean ± standard deviation; bfrequency (%); HDL = high-density lipoprotein; LDL = low-density lipoprotein; BMI = body mass index; SBMG = self-blood glucose monitoring.
The intention-to-treat analysis evaluated the primary and secondary outcomes. The primary outcome of the present study was HbA1c levels as presented in Table
Two-way ANOVA with repeated measures for primary and secondary outcomes.
Model | Intervention mean (SD) | Control mean (SD) | Significance | ||||||
---|---|---|---|---|---|---|---|---|---|
Effect size (Eta square) | |||||||||
9.3 (1.06) | 8.6 (1.01) | 7.9 (0.93) | 9.3 (1.1) | 9.3 (1.1) | 9.3 (1.1) | ||||
Group | 14.5 | 0.09 | |||||||
Time | 277.6 | 0.66 | |||||||
Group × time | 289.5 | 0.67 | |||||||
130.7 (9.4) | 129.3 (9.1) | 127.8 (9) | 133.9 (12.3) | 133.7 (12.1) | 133.3 (12) | ||||
Group | 5.9 | 0.01 | 0.04 | ||||||
Time | 59.1 | 0.29 | |||||||
Group × time | 25.7 | 0.15 | |||||||
85.8 (0.69) | 84.7 (0.67) | 83.4 (0.65) | 87.3 (0.69) | 87.3 (0.67) | 87.1 (0.65) | ||||
Group | 7.4 | 0.05 | |||||||
Time | 61.3 | 0.30 | |||||||
Group × time | 39.3 | 0.21 | |||||||
82.58 (11.08) | 82.21 (11.09) | 82 (10.89) | 83.75 (10.93) | 83.77 (10.91) | 83.82 (10.89) | ||||
Group | 0.68 | 0.41 | 0.01 | ||||||
Time | 4.69 | 0.01 | 0.03 | ||||||
Group × time | 7.17 | 0.01 | 0.04 | ||||||
28.69 (3.2) | 28.54 (3.2) | 28.55 (3.2) | 28.87 (3.4) | 28.87 (3.4) | 29.89 (3.4) | ||||
Group | 0.24 | 0.62 | 0.01 | ||||||
Time | 2.59 | 0.07 | 0.01 | ||||||
Group × time | 3.18 | 0.04 | 0.02 | ||||||
142.83 (34.4) | 141.66 (33.9) | 140.90 (33.7) | 142.09 (35.7) | 142.04 (35.6) | 142.01 (35.6) | ||||
Group | 0.00 | 0.96 | 0.01 | ||||||
Time | 40.41 | 0.22 | |||||||
Group × time | 33.82 | 0.19 | |||||||
173.1 (45.4) | 171.3 (43.8) | 169.09 (43.1) | 171.9 (48.4) | 170.7 (47.02) | 171.88 (46.8) | ||||
Group | 0.006 | 0.93 | 0.01 | ||||||
Time | 3.15 | 0.06 | 0.02 | ||||||
Group × time | 0.10 | 0.82 | 0.01 | ||||||
95.89 (30.04) | 95.59 (28.4) | 93.95 (27.9) | 92.68 (25.6) | 93.06 (25.4) | 94.15 (25) | ||||
Group | 0.16 | 0.68 | 0.01 | ||||||
Time | 0.15 | 0.85 | 0.01 | ||||||
Group × time | 5.62 | 0.22 | 0.39 | ||||||
53.68 (12.8) | 54.72 (11.6) | 55.38 (11.8) | 53.21 (12.4) | 53.21 (12.5) | 52.76 (12.6) | ||||
Group | 0.55 | 0.45 | 0.01 | ||||||
Time | 2.66 | 0.28 | 0.01 | ||||||
Group × time | 6.94 | 0.94 | 0.04 | ||||||
98.35 (13.95) | 113.47 (11.07) | 123.47 (11.31) | 98.06 (17.47) | 99.77 (14.48) | 98.44 (15.69) | ||||
Group | 34.3 | 0.19 | |||||||
Time | 152.2 | 0.52 | |||||||
Group × time | 138.7 | 0.49 | |||||||
57.80 (7.11) | 62.85 (5.50) | 66.79 (5.35) | 58.11 (7.50) | 58.04 (7.33) | 58.16 (7.23) | ||||
Group | 16.15 | 0.10 | |||||||
Time | 150.81 | 0.51 | |||||||
Group × time | 147.61 | 0.51 | |||||||
3.56 (1.22) | 4.67 (1) | 5.41 (1.15) | 3.71 (1.40) | 3.67 (1.37) | 3.73 (1.40) | ||||
Group | 16.7 | 0.10 | |||||||
Time | 228.5 | 0.62 | |||||||
Group × time | 221.6 | 0.61 | |||||||
50.42 (9.17) | 50.76 (9.06) | 50.67 (9.04) | 50.69 (8.90) | 50.34 (8.83) | 50.39 (8.71) | ||||
Group | 0.00 | 0.92 | 0.01 | ||||||
Time | 0.07 | 0.86 | 0.01 | ||||||
Group × time | 10.5 | 0.07 | |||||||
52.63 (9.31) | 54.33 (9.42) | 55.37 (9.61) | 55.83 (12.11) | 55.82 (12.63) | 55.91 (12.75) | ||||
Group | 0.88 | 0.34 | 0.01 | ||||||
Time | 43.6 | 0.23 | |||||||
Group × time | 39.3 | 0.21 | |||||||
12.15 (4.99) | 11.98 (4.97) | 11.95 (5.03) | 12.76 (4.66) | 12.84 (4.61) | 12.91 (4.50) | ||||
Group | 1 | 0.31 | 0.01 | ||||||
Time | 0.51 | 0.55 | 0.01 | ||||||
Group × time | 9.33 | 0.10 | 0.06 |
Note: Group: test of between-subject effects; Time: test of within-subject effect; Group × time: interaction between group by time; SD: standard deviation;
Two-way ANOVA with repeated measures over time revealed statistically significant differences in the changes in systolic blood pressure and diastolic blood pressure from baseline at time points (12 and 24 weeks) between the two groups (
Analysis indicated a significant group-by-time interaction for efficacy expectation, outcome expectation, and diabetes self-management behavior (
Interestingly, our findings showed a significant interaction effect of time × group for quality of life (
No statistically significant interaction effect of time × group in depression was found in our study (
We tested the hypothesis that nurse-led DSME program is effective in improving lifestyle, clinical, and psychosocial outcomes. Participants in the intervention group showed significant improvements in glycemic control, blood pressure, body weight, efficacy expectation, outcome expectation, self-management behaviors, and social support compared with patients in the control group. These improvements were sustained over a 24-week follow-up period.
No adverse effects of our intervention were reported by our subjects. In addition, none of the patients were hospitalized or died for hypoglycemia events. These findings indicate the patient’s acceptance of the intervention as well as the success of the logistics. Further multicenter studies with larger sample sizes are needed to strengthen our results.
We had a dropout rate of 5% in this 24-week follow-up study which is statistically considered to an acceptable figure. This result suggested that the intervention procedures were well tolerated and there were no complications. However, dropouts were more likely to occur in low or lower-middle income individuals. Financial problems are known to significantly affect diabetes self-management in varying ways [
The compliance and satisfaction of patients with the program were generally high, so the feasibility of implementing this intervention in a future trial on a broader scale is promising. The total cost of implementing the study intervention was $5000.
Unlike many previous studies that examined drug treatment effect on glycemic control, we employed a nurse-led DSME to improve self-management behaviors. Most of the antidiabetes drugs have serious adverse effects that led researchers to the selection of alternative strategies aiming at achieving a better control of diabetes. A recent controlled study suggests that a nurse-led DSME can achieve a greater decrease in HbA1c at 6 months [
There were no significant differences between groups in their lipid profiles. However, there was a nonsignificant tendency towards a greater improvement in lipid profiles that might be confirmed if we had the bigger sample size and longer follow-up period. Recent studies suggest that lipid profile values varied by season, tend to be worse in cold season than in the warm season [
This study was based on a theoretical construct of self-efficacy by Bandura, the perception of one’s ability to perform a task successfully [
Our findings showed a significant interaction effect of time × group for quality of life (
Social support is known as one of the emotional coping mechanisms that can positively influence the quality of life [
We found a significant improvement in social support throughout the study period. In contrast, no significant differences between groups were observed for quality of life and depression, which likely reflect the short follow-up period and lack of power to detect such changes. However, there was a nonsignificant trend towards greater improvements in quality of life and depression symptoms in the intervention group than in the control group that might be confirmed if we had the larger sample size and longer follow-up period. To substantiate the robustness of the findings, further detailed interventions with larger sample size and longer follow-up period are still required to confirm our results.
To the best of our knowledge, this is the first study of its kind conducted in Ilam province, in the western part of Iran.
This trial has many strengths. By using a randomized clinical trial, we ensured a robust study design, with reasonably well-matched pairs in groups. Eventually, we were successful in minimizing contamination between the two groups. The program was delivered by a facilitator trained to give a high-quality education program. We aimed to ensure that necessary education materials were available to all in a local language. This approach greatly increases the generalizability of our findings and therefore the possibilities to implement this program for use in other resource-limited settings.
Data were analyzed by the intention-to-treat approach to preserve the merit of randomization. At the end of the study, the response rate was higher than expected (more than 90%), minimizing the amount of missing data. We acknowledge that there are some limitations in our study. Participants were followed-up for a short period of time. A follow-up period of 6 months may be too short to evaluate the long-term effect of the self-management intervention. Further studies are needed to evaluate the long-term effects of the intervention. Our trial may have been underpowered to detect significant changes in some variables and as a result, some of our findings may be prone to type 2 error (i.e., discarding real associations). There was a substantially and statistically significantly greater improvement in the intervention group, which might be due to the Hawthorne effect. The Hawthorne effect can influence the behavior of the participant, potentially improve or modify their behavior in response to the fact that they knew they are being observed. However, a rigorous design was used to minimize and adjust the common bias and limitations associated with research.
In a cohort of 142 adults with T2DM, a single-center nurse-led DSME offered sustained benefits in clinical and lifestyle outcomes at 24 weeks. Facilitating self-efficacy has been found to improve longer-term health outcomes in patients with chronic health conditions [
The authors declare that they have no competing interests.
The authors gratefully acknowledge all participants of the study. This study was supported by University Putra Malaysia (UPM) in cooperation with the Ilam University of Medical Sciences, Ilam, Iran.