A Patient-Centered Self-Management Intervention to Improve Glycemic Control, Self-Efficacy and Self-Care Behaviors in Adults with Type 2 Diabetes Mellitus: A SPIRIT Compliant Study Protocol for Randomized Controlled Trial

Figures & data

Figure 1 Modified self-efficacy model.

Table 1 Description of the Intervention

Week	Delivery Time (Minutes)	SCT Application	Contents
Week 1	60 30	Physiological/emotive arousal Performance accomplishment, Self-appraisal	General disease knowledge including types, risk factors, clinical manifestations, complications, treatment options and self-management. Group discussion- sharing experiences of diabetes management.
Week 2	60 15 15	Physiologic/emotive arousal Vicarious experience, Verbal persuasion, Performance accomplishment	Self-care behaviors, role of self-care behaviors towards effective management of type 2 DM. Motivational video showing how patients with type 2 DM successfully improved self-care behaviors and avoided diabetes associated acute and chronic complications. Real stories of diabetic patient to serve as a role-model; to follow their daily routine of performing self-care activities. Provision of diabetes self-care guidebook.
Week 3	60	Performance accomplishment, Verbal persuasion, Social-structure; facilitators	Home visit-initiating and maintaining behavioral change with social support as a key strategy.  - Observation of personal, social and environmental facilitators helping in initiating and maintaining behavior change. - Observation of physical and social structural difficulties in initiating and ongoing barriers in maintaining behavior change. - Observation and discussion of personalized, family and social support strategies for dealing with the barriers.
Week 4	30 60	Physiologic/emotive arousal Individual (cognitive, personal, behavioral) factors; Social structural factors; Outcome expectations; Goal setting; Source of information: self-appraisal, verbal persuasion. Performance accomplishments	Diet; healthy dietary patterns, choosing the correct food, adjustments in eating plan.  - Identifying personal self-management needs, perceptions, beliefs and existing dietary behaviors. - Discussing on benefits of dietary behavioral change by providing examples of healthy and preferred choices over unhealthy and avoiding or limiting options. - Collaborative goal setting based on the interest and confidence subject has in their ability to change dietary behavior and enlisting specific goals in behavioral terms. - Identifying and listing of personal, social and environmental support (facilitators) and barriers (impediments) towards goal attainment (dietary behavior change). - Thinking of and listing strategies and problem solving techniques to overcome personal, social or environmental barriers. - Developing a follow-up plan including telephonic reminders to foster continued performance accomplishment.
Week 5	30 60	Physiologic/emotive arousal Individual (cognitive, personal, behavioral) factors; Social structural factors; Outcome expectations; Goal setting; Source of information: self-appraisal, verbal persuasion. Performance accomplishments	Physical activity; healthy exercise patterns, adjustments in vacation, illness and stress.  - Identifying personal self-management needs, perceptions, beliefs and existing behaviors regarding physical activity. - Discussing on benefits of regular physical activity by providing examples of healthy and preferred choices over unhealthy and avoiding or limiting options. - Collaborative goal setting based on the interest and confidence subject has in their ability to adopt physical activity routine and enlisting specific goals in behavioral terms. - Identifying and listing of personal, social and environmental support (facilitators) and barriers (impediments) towards goal attainment (regular physical activity). - Thinking of and listing strategies and problem solving techniques to overcome personal, social or environmental barriers. - Developing a follow-up plan including telephonic reminders to foster continued performance accomplishment.
Week 6	30 60	Physiologic/emotive arousal Individual (cognitive, personal, behavioral) factors; Social structural factors; Outcome expectations; Goal setting; Source of information: self-appraisal, verbal persuasion. Performance accomplishments	Foot hygiene; appropriate use of footwear and socks; foot care.  - Identifying personal self-management needs, perceptions, beliefs and existing behaviors of foot care. - Discussing on benefits of foot care by providing examples of foot care recommended over unhealthy foot care practices. - Collaborative goal setting based on the interest and confidence subject has in their ability to adopt daily foot care routine and enlisting specific goals in behavioral terms. - Identifying and listing of personal, social and environmental support (facilitators) and barriers (impediments) towards goal attainment (foot care). - Thinking of and listing strategies and problem solving techniques to overcome personal, social or environmental barriers. - Developing a follow-up plan including telephonic reminders to foster continued performance accomplishment.
Week 7	30 60	Physiologic/emotive arousal Individual (cognitive, personal, behavioral) factors; Social structural factors; Outcome expectations; Goal setting; Source of information: self-appraisal, verbal persuasion. Performance accomplishments	Medication adherence; taking medications, self-regulation, making adjustments.  - Identifying personal self-management needs, perceptions, beliefs and existing behaviors of taking medication. - Discussion on benefits of medication adherence by providing examples of compliance and health risks associated with non-compliance. - Collaborative goal setting based on individual needs and preferences and the confidence subject has in their ability to adopt medication routine. - Identifying and listing of personal, social and environmental support (facilitators) and barriers (impediments) towards goal attainment (medication adherence). - Thinking of and listing strategies and problem solving techniques to overcome personal, social or environmental barriers. - Developing a follow-up plan including telephonic reminders to foster continued performance accomplishment.
Week 8	60	Performance accomplishment, Self-appraisal, Verbal persuasion,	Booster session  - Reflection on what was learned in the previous sessions. - Performance feedback. - Reviewing behavioral goals fostering continued performance accomplishment and addressing difficulties of maintaining behavior change over time.

Table 2 Plan to Enhance the Fidelity of the Intervention

Sr.	Dimension of Fidelity of Intervention	Description and Strategies to Be Used
1	Delivery of the intervention: treatment delivery as planned	PI and RAs will deliver the intervention. RAs do not have working relationship with the institution where the study is designed nor the study hospital where the intervention will be administered. To control information bias, PI and RAs will be blinded to the baseline, post-intervention and follow-up results. Further procedures to improve fidelity of delivery of the intervention include: -  - Development and use of a manual of operations (MOO) to guide the training of RAs for the delivery of intervention protocol and to ensure consistency and reproducibility. - Uniform and standardized training of RAs. - Availability of essential resources and preparation of environment in which the intervention will be delivered. - Compliance with the intervention protocol by utilizing a checklist and noting any deviation from the protocol. - Observation of ongoing intervention sessions
2	Receipt of the intervention: Subjects’ demonstration of knowledge and ability to use the treatment.	The following strategies will be used to ensure that the subjects understand the content of the intervention and can use their cognitive and behavioral skills to perform the behaviors trained in the intervention:  - Summarizing the content at the end of each session. - Asking pre- and post-session questions to evaluate what is already known and what is taught. - Discussing material (provided) with the subjects. - Structuring behavior change around small achievable goals and objectives. - Using problem-solving techniques while creating situations in which the subject is asked to list strategies for overcoming barriers to behavior change. - Ensuring that subjects can apply the behavioral skills taught in the intervention (eg, choosing from food pyramid, reading food labels, setting timer/step counter, foot inspection, reading and interpreting blood sugar levels). - Having the provider work with subjects via SMS/phone calls to find out if they correctly understand and demonstrate the knowledge and skills taught.
3	Compliance with the treatment: Application of behavior change skills learned during the intervention in daily life of the subject.	The following strategies will be used to ensure that the subjects use their personal (cognitive and behavioral) skills and environment to maintain behavioral change:  - Provision of Urdu Booklet consisting relevant study materials. - Visiting subjects at their homes to evaluate the facilitators and barriers towards initiating and maintaining behavioral change; keeping a log for each subject and coming up with the strategies or action plan to work on minimizing those barriers. - Following-up through phone call conversations and SMS reminders. - Self-monitoring. - Uniform and consistent measurement of outcomes.

Table 3 Outcome Variables, Definition, and Instruments

Outcome	Definition	Instrument
Primary Outcome: Glycemic control	“Glycosylated hemoglobin (HbA1C) <7% as satisfactory diabetic control”.^Citation22	Conventional blood test for HbA1c
Secondary Outcomes: 1. Self-Efficacy towards self-management of type 2 DM 2. Self-care behaviors including: Diet control Physical activity Foot care Medication adherence	“Perceived capability to perform certain self-care behaviours”.^Citation12 “The self-care activities independently performed by diabetic patient including diet, exercise, foot care and medication intake”.^Citation23	Diabetes Management Self-efficacy Scale^Citation12 Summary of Diabetes Self-Care Activities (SDSCA) tool^Citation26

Table 4 Schedule of Events and Measurements

Event Description	Screening & Enrollment Phase	Intervention Phase								Follow-Up Phase
Study Visits/ Study Days/Weeks)	Visit-0	1	2	3	4	5	6	7	8
	*M0	W1	W2	W3	W4	W5	W6	W7	W8	**M1	***M2
Informed Consent	X
Demographic & Clinical History	X
HbA1C	X									X	X
Self-Efficacy	X									X	X
Self-Care Behaviors	X									X	X
ECB - Disease Introduction and control and management strategies		X
ECB – Role of Self-care behaviors, motivational video, role modeling and booklet provision			X
Home visit				X
ECB - Diet Control					X
ECB - Physical Activity						X
ECB – Foot Care							X
ECB – Medication Adherence								X
ECB – Booster									X
Study completion											X

Notes: *M0 baseline measurements; **M1 first follow-up measurements at the end of intervention; ***M2 last follow-up measurements after three months of the end of intervention.

Table 5 Study Hypotheses and Corresponding Test Statistic

Sr.	Hypotheses	Test Statistic
1	Ho: There is no difference in HbA1c between CG and IG H1: IG will have a reduction in HbA1c compared to CG	Independent t-test
2	Ho: There is no difference in self-efficacy between CG and IG H2: IG will have a greater self-efficacy towards management of type 2 DM than CG	Chi-square test
3	Ho: There is no difference in self-care behaviors between CG and IG H3: IG will have improved self-care behaviors than CG.	Chi-square test

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