SPIRIT Compliant Study Protocol on HbA1c | DMSO – Dove Medical Press

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Back to Journals » Diabetes, Metabolic Syndrome and Obesity » Volume 16
Authors Asmat K , Dhamani K , Froelicher ES, Gul R
Received 18 September 2022
Accepted for publication 17 December 2022
Published 26 January 2023 Volume 2023:16 Pages 225—236
DOI https://doi.org/10.2147/DMSO.S385715
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Konstantinos Tziomalos
Kainat Asmat,¹ Khairunnisa Dhamani,¹ Erika Sivarajan Froelicher,² Raisa Gul¹

¹Shifa College of Nursing & Midwifery, Shifa Tameer-e-Millat University, Islamabad, Pakistan; ²Department of Physiological Nursing, School of Nursing, Department of Epidemiology & Biostatistics, School of Medicine, University of California, San Francisco, CA, USA

Correspondence: Kainat Asmat, Shifa College of Nursing & Midwifery, Shifa Tameer-e-Millat University, Islamabad, Pakistan, Tel +923427892627, Email [email protected]

Background: The rising burden of type 2 diabetes mellitus (DM) and its associated complications is affecting the functional capacity of the individuals, their quality of life and demand for healthcare services with significant economic impact on health care systems and the national economies. Given the enormous health and economic impact, preventing type 2 DM progression and reducing the risk of complications require immediate attention. Evidence from western countries suggests that self-management can slow the progression of type 2 DM and minimize the risk of major complications lowering health-care costs. Effective self-management, however, demands patients’ confidence and their full commitment to perform self-care tasks necessitating a patient-centered approach. This study aims to test the efficacy of a patient-centered self-management intervention to improve glycemic control, self-efficacy and self-care behaviors in adults with type 2 DM.
Patients and Methods: The study will be carried out as a parallel arm, randomized, controlled trial in four public tertiary care hospitals in Faisalabad, Pakistan. A total of 612 patients with type 2 DM will be recruited and randomly assigned to two groups: a control and an intervention group. The intervention group will receive a patient-centered self-management intervention for eight weeks duration. Subjects will be followed up for three months. The primary outcome will be glycemic control (HbA1c), and secondary outcome variables will include self-efficacy and self-care behaviors all measured at three points in time (baseline, at the end of intervention and at three months follow-up).
Discussion: This randomized controlled trial will provide critical information about the efficacy of patient-centered self-management intervention in improving HbA1c, self-efficacy and self-care behaviors. If successful, this evidence-based care intervention may be provided to all DM patients by updating hospital policies.
Trial Registration: NIH: US National Library of Medicine clinicaltrials.gov Identifier: NCT05491252, Shifa Tameer e Millat University Protocol Record: 335-21. Registration date: August 08, 2022. Recruitment began: April 21, 2022. Recruitment completed: July 27, 2022. URL http://www.clinicaltrials.gov.

Keywords: education, counselling, HbA1c, patient-centered care, type 2 diabetes, self-management, randomized controlled trial

Diabetes mellitus (DM) is one of the major health problems of the 21st century due to its growing prevalence and the risk of increased morbidity and mortality.¹ The International Diabetes Federation (IDF) estimated that by 2021, one in every ten adults aged 20 to 79 had DM, equivalent to 537 million people worldwide.² According to the IDF report, prevalence is higher in the Middle East and North Africa, particularly in low- and middle-income countries, where three out of every four adults are affected.² Pakistan, a low-middle income country with 225 million population, is ranked third among the top 10 countries in terms of absolute rise in DM prevalence.² Pakistan has 33 million people (aged 20–79 years) with DM and this number is expected to nearly double (62 million) by 2045.³ With one in every four adults (26.7%) living with DM in Pakistan, type 2 DM accounts for more than 90% of cases.³
The rise in type 2 DM in Pakistan is mostly due to environmental, demographic, socioeconomic and genetic factors with important contributors being sedentary lifestyle, unhealthy eating habits and obesity.⁴ Furthermore, a poor healthcare system characterized by inequity in health care services provision, poor socioeconomic conditions, lack of education and unemployment are exacerbating the problem.⁵ The rising burden of type 2 DM and its associated complications is affecting the functional capacity of the individuals, their quality of life and the demand for healthcare services.⁶ Moreover, it is adding to the financial burden of individuals and their families with significant economic impact on the healthcare system and the national economy.⁷ Given its enormous health and economic impact, preventing type 2 DM progression and reducing the risk of associated complications requires immediate attention in order to improve the quality of life of affected individuals and lower the burden of the country’s already debilitated healthcare system.
Evidence from western countries suggests that self-management can delay the progress of type 2 DM and can reduce the risk of serious complications thereby, reducing the cost of health care.⁸ Effective self-management however, necessitates patients’ confidence and their full commitment to perform self-care tasks.⁹ A patient-centered approach is therefore necessary because patients must make a determined and self-motivated effort to adopt a healthy lifestyle and to achieve optimum glycemic control. A recent systematic review and meta-analysis provide evidence supporting that patient-centered care improves glycemic control and self-care behaviors in adults with type 2 DM.¹⁰
Though several studies have been published on self-management of type 2 DM in Pakistan, only a few randomized controlled trials (RCTs) have been published that focus on educational interventions. Type 2 DM is associated with complexity as there are multiple risk factors, mostly involving behavioral or social components, which the individual, family or society has to struggle hard to implement. Therefore, a patient-centered behavioral or social intervention would make a long-lasting impact towards effective disease management. The purpose of this study is to test a patient-centered self-management intervention guided by Social Cognitive Theory, with the goal of improving glycemic control, self-efficacy and self-care behaviors in adults with type 2 DM.
Social Cognitive Theory (SCT) by Albert Bandura,¹¹ forms the conceptual bases whereas, the model of self-efficacy¹² derived from SCT, provides the framework for this study.
SCT provides a solid theoretical underpinning for understanding how individuals learn and sustain certain behaviors.¹³ According to SCT, learning occurs in a social context through the dynamic and reciprocal interaction of the personal (ie, cognitive, affective, and biological events), behavioral and environmental factors.¹⁴ The SCT is appropriate for understanding self-care behaviors of adults with type 2 DM as the reciprocal interaction between the personal, behavioral and environmental factors that directly influence the performance of self-care activities in this population.¹⁵ The main construct of SCT is self-efficacy (the core predictor of behavior) which refers to the confidence an individual has in his or her ability to effectively execute a particular behavior and achieve the desired outcome.¹⁶ According to Bandura, self-efficacy is a very effective predictor of behavior change. Therefore, compared to those with a low level of self-efficacy, people who have a high level of self-efficacy are more likely to succeed when faced with challenges.¹⁶
The modified self-efficacy model (see Figure 1) exhibits the relationship between self-efficacy, outcome expectations, social-structure, behavior and outcomes. Self-efficacy, outcome expectations and social-structure directly influence behavior whereas; behavior and outcome expectations directly influence outcomes. Moreover, sources of information directly influence self-efficacy of the individual. The basic concept behind using this model in the study is that individual’s demographics and perceptions, combined with strong self-efficacy, would result in improved performance of self-care activities, thereby improving glycemic control and self-care behaviors in adults with type 2 DM.

Figure 1 Modified self-efficacy model.

Figure 1 Modified self-efficacy model.
A randomized controlled trial (RCT) with parallel arm design will be used to test the effectiveness of the intervention.
Pakistan’s healthcare system is composed of two parts: private and public. The public sector health service delivery system is divided into three levels; primary, secondary and tertiary.¹⁷ Primary level consists of basic health units (BHU) and rural health centers (RHC) which provide curative and preventive health services. The secondary level consists of Tehsil headquarters (THQ) and district headquarters (DHQ) providing technical, therapeutic and diagnostic services. Tertiary level hospitals provide specialized health services for inpatients and referrals from primary and secondary levels.¹⁸ The proposed study will take place in the outdoor patient departments (OPD) of four public tertiary level hospitals in Faisalabad city. Each hospital has an OPD with a turnover of average 50–100 patients per day.

• Adult (aged 18 years or above).
• Diagnosed with type 2 DM for at least 6 months duration.

• Uncontrolled psychological comorbidity (psychosis, schizophrenia, dementia or severe learning difficulties).
• Type 2 DM patients with HbA1c < 7.
• Severe comorbidity that may limit participation (medical conditions such as cancer, stroke with disabilities, or need for regular dialysis, etc. that preclude complete participation in this study).
• Life expectancy of less than six months as determined by patient’s primary physician.
• Living outside of the Faisalabad City.

The required sample size for this study, is calculated through statistical power analysis utilizing G*Power 3.1 software. G*Power 3.1 calculator revealed that using an alpha level (α) of 0.05, a power factor (1-β) of 0.80 and an effect size of 0.23 (the largest of all outcome variables calculated from a previous study with similar characteristics);¹⁹ a sample size of 470 subjects will be required with minimum 235 in each group. Considering the possible dropout of about 30%; 612 subjects will be targeted in this study with 306 in each group.
The principal investigator (PI) will screen all the consecutive medical records at study hospitals to identify potential subjects. The individuals meeting the eligibility from medical records, will be invited for a screening appointment. The individuals fulfilling the inclusion criteria and violating none of the exclusion criteria, will be invited to participate by providing detailed project information and offering the opportunity to ask questions (if any). Subjects who provide the written informed consent will be included in the study.
Recruited subjects will be randomized into two groups: (1) the control group (CG) and (2) the intervention group (IG). Stratified permuted block randomization procedure will be used to produce separate random schemes for each setting (hospital A, B, C and D). Sealed envelopes (of block sized CG and IG) will be prepared, shuffled via simple randomization technique and then will be numbered serial-wise to be placed in the boxes (designated for each setting labelled as A, B, C and D). Randomization will be performed by data analyst (DA). PI or any other members of research team will not be involved in randomization to avoid any influence. The PI will be responsible for the randomization plan implementation and documentation. Once the PI has determined that the subject meets the eligibility criteria and has given informed consent to be randomized to either the CG or the IG, the PI will withdraw a numbered, sealed envelope from the box (for that setting) and open it in front of the subject. The PI will document the process and secure the opened envelopes with the serial numbers for record and audit purpose.
Due to the nature of the intervention, blinding at all levels is not possible because the subjects receiving the intervention cannot be kept “blinded” or “masked”. The research staff designated as data collector (DC) and data analyst (DA) will be blinded about which group the subject is assigned to. Baseline data will be collected on all subjects before randomization to preclude any bias in baseline data collection. Similarly, DCs will be blinded with regards to subjects’ group assignment when collecting outcome information.
The subjects in the CG will receive usual care. Usual care at the study hospitals involves consultation with the physician encompassing a brief history taking, blood glucose measurement, record keeping and provision of general education regarding lifestyle modification verbally or in the form of pamphlets.
The subjects in the IG will receive usual care as well as a nurse-led PAtient CEntered Self-Management Intervention (PACE-SMI). PACE-SMI is based on the core determinants of human behavior in SCT which include personal (cognitive, affective, biological) factors, efficacy-expectations, sources of information, outcome expectations, behaviors and socio-structural (perceived social support and barriers) factors. The contents of the intervention are further informed by the American Association of Diabetes Educators (AADE) seven self-care behaviors including healthy eating, healthy coping, being active, monitoring, taking medication, reducing risk and problem solving.²⁰ Table 1 outlines the contents of PACE-SMI with underlying SCT application. PACE-SMI will be delivered for eight weeks duration (comprising 8 weekly face-to-face individualized educational, counselling and behavioral training sessions) in the OPD room at each study hospital by the PI and RA who are nurses with at least bachelor’s degree education in nursing and underwent two days of training provided by the PI.

Table 1 Description of the Intervention

Table 1 Description of the Intervention
The fidelity of the intervention plan (shown in Table 2) is developed in accordance with the recommendations of the National Institute of Health (NIH) behavior change consortium, which provides methodological strategies aimed at monitoring and improving the consistency, reliability and validity of behavioral interventions.²¹

Table 2 Plan to Enhance the Fidelity of the Intervention

Table 2 Plan to Enhance the Fidelity of the Intervention
Table 3 summarizes the specific outcome variables, their definitions and corresponding measurement instruments.

Table 3 Outcome Variables, Definition, and Instruments

Table 3 Outcome Variables, Definition, and Instruments
Glycemic control (HbA1c) will be measured by collecting venous plasma samples and sending them to the single central laboratory to assure consistency and uniformity in methodology. The DC (trained nurse) will draw the sample and laboratory measurements will be performed by laboratory technician. HbA1c <7% indicates satisfactory glycemic control whereas, HbA1c value ≥7% indicates poor glycemic control.²²
Self-efficacy will be measured on the diabetes management self-efficacy scale (DMSES). DMSES is a self-administered scale used to assess subjects’ perceived confidence in their ability to manage blood sugar, diet, physical activity and foot care. The scale is comprised of 20 items. Each item’s response is rated on an 11-point scale ranging from 'cannot do at all (0)’ to 'certain can do it' (10) with a total score 0 to 200. A higher score would indicate high self-efficacy. DMSES was developed by Van Der Bijl (1999) to measure diabetes management self-efficacy of patients with type 2 DM. Psychometric properties of DMSES showed acceptable reliability and validity (α = 0.81; r = 0.79).²⁴ The translated Urdu version of DMSES (U-DMSES to be used in this study) was reported to have α = 0.93.²⁵
Self-care behaviors will be measured on the Summary of Diabetes Self-Care Activities (SDSCA) questionnaire. The SDSCA tool developed and revised by Toobert et al; is a self-reported scale to measure self-care activities across diverse components of diabetes self-management.¹⁶ A revised version of SDCA scale measures seven components of diabetes self-management including general diet, specific diet, exercise, blood glucose testing, medication adherence, foot care and smoking.²⁶ SDSCA is comprised of 25 items with each item measuring the frequency of self-care activities by asking how often several self-care activities were carried out over the past seven days period. Each item’s response is rated on a 7-point scale ranging from “0” to “7” with a total score ranging from 0 to 175. A higher score would be the frequency of performing self-care activities.
Primary and secondary outcome variables will be measured at three points in time (at baseline, at the end of intervention and at follow-up after three months from the end of intervention). Table 4 illustrates the schedule for events and measurements for this study.

Table 4 Schedule of Events and Measurements

Table 4 Schedule of Events and Measurements
In order to evaluate the effect of the intervention over time, the subjects will be followed up for three months starting from the end of intervention. During the three months follow-up, phone conversations and regular SMS reminders would be used to encourage behavior maintenance. Follow-up measurements will be carried out at an in-person visit of the subject to the study hospital.
Double data entry will be employed in order to increase the accuracy of data entered into a computerized data file. The data will also be checked for missing values, logical inconsistencies and outliers. The data will be analyzed using the Statistical Package for the Social Sciences (SPSS, version 22.0). The CG and IG’ demographic and clinical variables will be described using descriptive statistics (mean and standard deviation (±SD) for continuous variables and frequency and percentage for categorical variables). In order to confirm that randomization worked, important demographic and clinical data will be presented in a table to see the equal distribution between the two groups. Independent t-test will be used to determine the differences on continuous data (mean score differences between CG and IG). Chi-square test will be used to determine the differences on categorical data (differences in proportion between CG and IG). Table 5 below shows the hypotheses with corresponding test statistics to be applied.

Table 5 Study Hypotheses and Corresponding Test Statistic

Table 5 Study Hypotheses and Corresponding Test Statistic
Intention to treat (ITT) analysis principle will be used to achieve an unbiased estimate of effect of the intervention. ITT is a method in which all randomized subjects are included in the statistical analysis and analyzed based on the group to which they were initially assigned, regardless of the treatment/care they have received.²⁷
Previous randomized controlled trials of type 2 DM self-management interventions have shown a reduction in HbA1c and improvement in self-care behaviors in several countries.^28–30 Focusing on a patient-centered approach, a recent systematic review and meta-analysis provided the evidence that patient-centered care improves glycemic control (HbA1c) and self-care behaviors in adults with type 2 DM.¹⁰ The stratified analysis of HbA1c in this systematic review and meta-analysis, witnessed the largest effect size in interventions delivered by nurses. To date, nurse-led educational and behavioral intervention have not been formally tested in type 2 DM patients in Pakistan. This will be the first trial to demonstrate a theory-based nurse-led educational, counselling and behavioral intervention in adults with type 2 DM with the goal of empowering them to manage their own care and improving health outcomes in terms of HbA1c, self-efficacy and self-care behaviors. If this study proves successful, the trial will demonstrate that such interventions enable individuals to make informed decisions about their condition, resulting in better health outcomes, a higher quality of life, and a positive impact on the economy of the family and the health system. It’s also worth noting that if PACE-SMI shows efficacy in type 2 DM self-management, similar interventions could be applied to other chronic conditions.
This study may also have some limitations. Because this study requires long-term engagement, some subjects may decline to participate or find it difficult to consistently attend all the intervention sessions due to economic and sociocultural differences. To enhance retention, the following procedures will be used: (1) encouraging the subjects to stay in the study and attend all sessions by emphasizing the importance of self-management of their disease, (2) visit reminder in the form of a postcard at the end of each visit and SMS reminder one day prior to the scheduled visit, (3) financial incentive in lieu of traveling cost (to and from the study hospital), (4) two phone numbers of significant others (family, friends or relatives) to locate the missing subject, if he/she has not withdrawn consent and (5) accessing missing subjects in their homes, if given consent for home visits.
AADE, American Association of Diabetes Educators; DM, diabetes mellitus; DA, data analyst; DC, data collector; IDF, International Diabetes Federation; NIH, National Institute of Health; PCC, patient-centered care; PI, principal investigator; RCT, randomized controlled trial; WHO, World Health Organization.
The trial will be conducted in accordance with the Declaration of Helsinki. This study has been approved by the Institutional Review Board and Ethics Committee (IRB and EC) of Shifa Tameer e Millat University (protocol reference number 335-21) and the Ethical Review Committee (ERC) of the study hospitals under the care of Faisalabad Medical University (protocol reference number 48.ERC/FMU/2020-21/193). Protocol modifications will be accordingly approved by IRB and ERC. This trial has been registered in the US National Library of Medicine Clinical Trial Register (clinicaltrials.gov Identifier: NCT05491252). Following eligibility screening, written informed consent will be obtained after providing information about the project’s details which include a brief description of (1) the study’s purpose, (2) methodology, (3) duration of the study and (4) subject’s right of voluntary participation and withdrawal at any time during the course of the study. The protection and confidentiality of personal data will be guaranteed. To preserve confidentiality, all soft data will be encrypted and kept in a password protected laptop and hard data (paper documents) will be kept in a locked cabinet. If the proposed intervention shows a positive effect in relation to the studied outcomes, the intervention will also be offered to the subjects in the control group at the end of the study. The findings of this trial will be accurately reported and published in a peer-reviewed international scientific journal.
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
This study has received partial funding from Shifa Tameer e Millat University, Islamabad, Pakistan.
The authors report no conflicts of interest in this work.
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