A randomized controlled study to evaluate the effect of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among type 2 diabetes patients: A consort compliant study protocol

Allah Bukhsh, Muhammad Sarfraz Nawaz, Hafiz Sajjad Ahmed, Tahir Mehmood Khan, Allah Bukhsh, Muhammad Sarfraz Nawaz, Hafiz Sajjad Ahmed, Tahir Mehmood Khan

Abstract

Background: Diabetes self-care activities, like, healthy diet, regular exercise, self-monitoring of blood glucose, and rational use of medicines are considered to play a vital role in establishing euglycemia. Health literacy among type 2 diabetes mellitus (T2DM) patients in Pakistan is very low, which is the most likely cause for poor clinical outcomes. This study is designed to investigate the impact of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among T2DM patients in Pakistan.

Methods: In this randomized controlled trail, effectiveness of a 6-month pharmacist-led educational intervention will be examined on glycemic control, diabetes self-care activities and disease knowledge of 80 adult T2DM patients (age >30 years) with poorly controlled T2DM (HbA1c> 7%), after randomizing them into intervention and control groups, at diabetes care clinic of Capital Hospital Islamabad, Pakistan.

Results: The primary outcome is change in patients' HbA1c, whereas, changes in self-care activities and patients' disease knowledge are the secondary outcomes. After baseline assessment of their self-care activities and disease knowledge by using validated Urdu versions of Diabetes Self-management Questionnaire (DSMQ) and Diabetes Knowledge Questionnaire (DKQ), respectively, interventional group patients will be supplemented with a face-to-face pharmacist-led educational intervention, whereas, the control group will receive usual care. Intervention arm patients will be educated successively at their first follow-up visit (12th week) and telephonically after every 4 weeks. All assessments will be made at baseline and end of trail for both intervention and control groups. Multivariate general linear model will be applied to analyze the effects of the intervention.

Conclusion: Glycemic control in T2DM patients requires optimum self-care activities. This study is an attempt to improve self-care behaviors among poorly controlled T2DM patients who are at higher risk of diabetes-associated late complications.

Conflict of interest statement

The authors report no conflicts of interest.

Figures

Figure 1
Figure 1
Study Flow Diagram.

References

    1. Organization WH. Diabetes. 2016; , 2017.
    1. Organization WH. Global report on diabetes. 2016; .
    1. Lu Y, Xu J, Zhao W, et al. Measuring Self-Care in Persons With Type 2 Diabetes A Systematic Review. Eval Health Prof 2016;39:131–84.
    1. Atlas IDFI. IDF DIABETES ATLAS 2016; 7TH EDITION:. Accessed Febuary 13, 2016.
    1. Raaijmakers LG, Martens MK, Bagchus C, et al. Correlates of perceived self-care activities and diabetes control among Dutch type 1 and type 2 diabetics. J Behav Med 2015;38:450–9.
    1. Bahadar H, Mostafalou S, Abdollahi M. Growing burden of diabetes in Pakistan and the possible role of arsenic and pesticides. J Diabetes Metab Disord 2014;13:1.
    1. Hussain A, Ali I. Diabetes mellitus in Pakistan: a major public health concern. Arch Pharm Pract 2016;7:30.
    1. Qidwai W, Ashfaq T. Imminent epidemic of diabetes mellitus in Pakistan: issues and challenges for health care providers. 2010.
    1. Conditions NCCfC. Type 2 diabetes: national clinical guideline for management in primary and secondary care (update): Royal College of Physicians (UK); 2008.
    1. Xu WH, Rothman RL, Li R, et al. Improved self-management skills in Chinese diabetes patients through a comprehensive health literacy strategy: study protocol of a cluster randomized controlled trial. Trials 2014;15:498.
    1. Selvin E, Marinopoulos S, Berkenblit G, et al. Meta-analysis: glycosylated hemoglobin and cardiovascular disease in diabetes mellitus. Ann Intern Med 2004;141:421–31.
    1. Ko JJ, Lu J, Rascati K, et al. Analysis of glycemic control of a pharmacist-led medication management program in patients with type 2 diabetes. J Manag Care Spec Pharm 2016;22:32–7.
    1. Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy 2008;28:421–36.
    1. Pousinho S, Morgado M, Falcão A, et al. Pharmacist interventions in the management of type 2 diabetes mellitus: a systematic review of randomized controlled trials. J Manag Care Spec Pharm 2016;22:493–515.
    1. Gucciardi E, Chan VW-S, Manuel L, et al. A systematic literature review of diabetes self-management education features to improve diabetes education in women of Black African/Caribbean and Hispanic/Latin American ethnicity. Patient Educ Couns 2013;92:235–45.
    1. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: A systematic review of the effect on glycemic control. Patient Educ Couns 2016;99:926–43.
    1. Sturt JA, Whitlock S, Fox C, et al. Effects of the Diabetes Manual 1: 1 structured education in primary care. Diabet Med 2008;25:722–31.
    1. Parker RM, Williams MV, Weiss BD, et al. Health literacy-report of the council on scientific affairs. JAMA 1999;281:552–7.
    1. Li R, Zhang P, Barker LE, et al. Cost-effectiveness of interventions to prevent and control diabetes mellitus: a systematic review. Diabetes Care 2010;33:1872–94.
    1. Machado M, Bajcar J, Guzzo GC, et al. Sensitivity of patient outcomes to pharmacist interventions. Part I: systematic review and meta-analysis in diabetes management. Ann Pharmacother 2007;41:1569–82.
    1. Smith M. Pharmacists’ role in improving diabetes medication management. J Diabetes Sci Technol 2009;3:175–9.
    1. Wagner EH, Sandhu N, Newton KM, et al. Effect of improved glycemic control on health care costs and utilization. JAMA 2001;285:182–9.
    1. Butt M, Ali AM, Bakry MM, et al. Impact of a pharmacist led diabetes mellitus intervention on HbA1c, medication adherence and quality of life: A randomised controlled study. Saudi Pharm J 2016;24:40–8.
    1. Ali M, Schifano F, Robinson P, et al. Impact of community pharmacy diabetes monitoring and education programme on diabetes management: a randomized controlled study. Diabet Med 2012;29(9.):
    1. Hayward RA, Krein SL, Vijan S. Proactive case management of high-risk patients with type 2 diabetes mellitus by a clinical pharmacist: a randomized controlled trial. Am J Manag Care 2005;11:253.
    1. Chen SM, Creedy D, Lin H-S, et al. Effects of motivational interviewing intervention on self-management, psychological and glycemic outcomes in type 2 diabetes: a randomized controlled trial. Int J Nurs Stud 2012;49:637–44.
    1. Sarkadi A, Rosenqvist U. Experience-based group education in Type 2 diabetes: a randomised controlled trial. Patient Educ Couns 2004;53:291–8.
    1. Moreira RC, de Fátima Mantovani M, Soriano JV. Nursing Case Management and Glycemic Control Among Brazilians With Type 2 Diabetes: pragmatic clinical trial. Nurs Res 2015;64:272–81.
    1. Bukhsh A, Lee SWH, Pusparajah P, et al. Psychometric Properties of the Urdu Version of Diabetes Knowledge Questionnaire. Front Public Health 2017;5:139.
    1. Schmitt A, Gahr A, Hermanns N, et al. The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control. Health Qual Life Outcomes 2013;11:1.
    1. Castejón AM, Calderón JL, Perez A, et al. A community-based pilot study of a diabetes pharmacist intervention in Latinos: impact on weight and hemoglobin A1c. J Health Care Poor Underserved 2013;24:48–60.
    1. Morello CM, Christopher ML, Ortega L, et al. Clinical outcomes associated with a collaborative pharmacist-endocrinologist diabetes intense medical management “tune up” clinic in complex patients. Ann Pharmacother 2016;50:8–16.
    1. Jahangard-Rafsanjani Z, Sarayani A, Nosrati M, et al. Effect of a Community Pharmacist–Delivered Diabetes Support Program for Patients Receiving Specialty Medical Care: A Randomized Controlled Trial. Diabetes Educ 2015;41:127–35.
    1. Farsaei S, Sabzghabaee AM, Zargarzadeh AH, et al. Effect of pharmacist-led patient education on glycemic control of type 2 diabetics: a randomized controlled trial. J Res Med Sci 2011;16:43.
    1. Qayyum AA, Lone SW, Ibrahim MN, et al. Effects of diabetes self-management education on glycaemic control in children with insulin-dependent diabetes mellitus. J Coll Physicians Surg Pak 2010;20:802–5.
    1. Mehuys E, Van Bortel L, De Bolle L, et al. Effectiveness of a community pharmacist intervention in diabetes care: a randomized controlled trial. J Clin Pharm Ther 2011;36:602–13.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する