Effect of Conversation Map on Diabetes Management Self-efficacy and Diabetic Distress Among Type 2DM Patient in Pakistan: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from baseline Diabetes Management Self-Efficacy (DMSE) at 3 months:
研究概览
简要总结
Background Diabetes is recognized as an important cause of premature death and disability. Non-clinical interventions play an important role in the control of diabetes and the prevention of its associated complications. Traditional methods of educating diabetic patients to empower them for the control of their disease might not work in the developing world. However, the novel interactive and pictorial health education tool named Diabetes Conversation Map (DCM) might be effective for the improvement of diabetes management self-efficacy and distress among diabetic patients in lower middle income setting of Karachi, Pakistan.
Objective To assess the effectiveness of DCM as compared to routine care to improve the diabetes management self-efficacy (DMSE) and diabetic distress (DD) among type 2 diabetic patients (T2DM) visiting diabetic clinics of tertiary care hospitals in lower middle income setting of Karachi, Pakistan.
Methodology This will be a two arms randomized controlled trial, conducted in two tertiary care hospitals, Karachi. A sample of 120 T2DM patients of age 30 - 60 years with sub-optimal diabetes control will be screened through eligibility criteria and diabetes distress screening tool. Patients who fulfill the eligibility criteria and have diabetes distress will be randomized into intervention (n=60) and control group (n=60) using sealed envelopes. The intervention arm will receive four diabetic education sessions using the DCM in a group of 5-8 participants and each session will be at the interval of one (1) week, by the principal investigator. T2DM patients in the controlled arm will receive routine care. Data on DMSE and DD will also be measured 2-3 months post intervention after the completion of all education sessions. Descriptive statistics will be used for data analysis through SPSS version 20; whereas, application of Repeated Measures ANOVA will be carried out for inferential statistics.
详细描述
Like any other chronic disease, the control of diabetes is very essential. Non-clinical interventions such as life style modification, stress relief and healthy dietary habits have been proven to be effective against the control of diabetes and prevention of diabetes related complications. Traditionally, diabetic patients used to receive education related to their disease process, metabolic control, exercise and diabetic diet through didactic lectures, brochures, pamphlets, and face to face counseling. While these traditional methods are found to be effective in diabetes self-management in the western world due to better literacy rate, level of understanding and access to modern modes of communications. However, in the developing world these methods could not work because of several reasons including poor literacy. Among novel methods, Diabetes Conversation Maps are considered as useful tools for the educational empowerment of diabetic patients. These are interactive pictorial tools designed in such a way that it does not need formal education for common understanding. In developing countries like Pakistan, where the literacy rate is very less, these tools might prove to be effective for the control of diabetes and its associated complications. Diabetes conversation maps have been used and tested in several countries predominantly in the developed world. In the developing region, while it has shown some impact during the observational studies, literature generated from randomized control trials is still limited. Patients in the developing region has different level of education and environmental exposures such as access to internet and social media, they have different socio-demographic characteristics and hence might behave differently from their counterparts in the developed world. Therefore, there is a need of well-designed randomized controlled trial to evaluate the effectiveness of Diabetes Conversation Map versus routine diabetic care in DMSE and DD in a low middle income setting of Karachi, Pakistan.
Research Question Is effectiveness of DCM as an educational tool same as routing care for improving the DMSE and DD in patients with T2DM visiting diabetic clinic of a tertiary care hospital in Karachi, Pakistan? 1.2 Significance of study: This study is a pioneer effort for generating new knowledge about the use of Diabetes Conversation Map. Findings of this study will be helpful for the nursing leadership and organizational leadership for use of Diabetes Conversation Map for managing the risks factors / complications of the DM. Also, it is cost effective intervention to be implemented by the health professionals, resulting in saving patients from managing DM, its complications, money and time. Moreover, findings of this study will be available for Pakistan Nursing Council (PNC) and Pakistan Medical and Dental Council (PMDC), for inculcating it into the curricula.
1.3 Hypothesis 1.3.1. H0: The effectiveness of DCM as educational tool is same to routine diabetic education among patients with diabetes type 2 (T2DM) visiting diabetic clinic in a tertiary care hospital of Karachi, Pakistan.
1.3.2. Ha: The effectiveness of DCM as educational tool is different to routine diabetic education among patients with diabetes type 2 (T2DM) visiting diabetic clinic in a tertiary care hospital of Karachi, Pakistan.
1.4 Objective of the study The objective of this study is to assess the effectiveness of DCM as an educational tool in comparison to routine care for improving the DMSE and DD among patients with type 2 diabetes mellitus visiting diabetic clinic of tertiary care hospital in Karachi, Pakistan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of both gendersage 30-60 years diagnosed with type 2 diabetes mellitusfor at least 5 years, presenting at the diabetes clinics of study setting and considered by health care professional to have a suboptimal management of their disease.
- •Patient having HbA1c more than 7 will be included
- •Patients who have not participated in any diabetic educational program before.
- •Patients who will be found to be diabetes distressed as recommended in diabetes distress (DD) screening tool
排除标准
- •Patients with major disabilities, diagnosed with mental health problems/ cognitive pattern not intact and those with major diabetes related complications.
- •Patients residing outside of Karachi or intended to leave the city during the study duration will be excluded.
研究组 & 干预措施
Experimental Arm
Intervention: Diabetic Conversation Map x 4 Sessions
干预措施: Diabetic Conversation Map (Behavioral)
Control Arm
No intervention
结局指标
主要结局
Change from baseline Diabetes Management Self-Efficacy (DMSE) at 3 months:
时间窗: at baseline and after 3 months of enrollment
The change in DMSE will be measured using validated DMSE scale. The scale has 20 items comprised of 4 domains; 1) nutrition specific and weight, 2) medical treatment, 3) physical exercise, 4) blood sugar. Each item is scored on 11 point likert scale (0=completely unable to 10=completely able). Possible score ranges from 0 to 200, with higher score representing higher self-efficacy.
Change from baseline Diabetes distress (DD) 3 months:
时间窗: baseline and 3 months of enrollment
The change in DD will be screened using validated DD scale. The scale has two parts; part 1 is consisting of two items asking about feelings of overburden due to demands of living with diabetes and feelings of failure with diabetes routine; the aim of part 1 is to screen for the presence of DD. Part 1 will be administered before the enrollment of the patient to screen for the presence of DD. If DD is present, part 2 will begin consisting of 17 items to score the extent of DD. Each item is scored on a likert scale ranging from 1 (not a problem) to 6 (a very serious problem). According to the instructions of DDS scoring sheet, total DDS will be measured with mean score while dividing the sum of all items by 17.The mean score of ≥3 will be the threshold for being distressed.
次要结局
- Change from baseline HbA1C at 3 months:(baseline and 3 months after enorllment)
研究者
Rubina Qasim
Lecturer
Dow University of Health Sciences