Diabetes Clinical Trial
— CrewDOfficial title:
Close Reading and Creative Writing - CrewD Program. An Alternative Educational Method for Group Care Intervention in Type 2 Diabetes Management. A Randomized Trial
Verified date | September 2018 |
Source | Associacao Protectora dos Diabeticos de Portugal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is related to the development of a new model of Group Care for patients with Diabetes - the CrewD Program, incorporating close reading and creative writing in group education. A randomized trial was designed to evaluate this intervention.
Status | Completed |
Enrollment | 49 |
Est. completion date | September 30, 2017 |
Est. primary completion date | September 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Only patients with type 2 diabetes of >1 year known duration, aged < 85 years were included in the intervention. Exclusion Criteria: - Patients that did not complete the four assessments. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Associacao Protectora dos Diabeticos de Portugal |
Charon R, Hermann N, Devlin MJ. Close Reading and Creative Writing in Clinical Education: Teaching Attention, Representation, and Affiliation. Acad Med. 2016 Mar;91(3):345-50. doi: 10.1097/ACM.0000000000000827. — View Citation
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 Jun;99(6):926-43. doi: 10.1016/j.pec.2015.11.003. Epub 2015 Nov 22. Review. — View Citation
Ferraro LA, Price JH, Desmond SM, Roberts SM. Development of a diabetes locus of control scale. Psychol Rep. 1987 Dec;61(3):763-70. — View Citation
Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. — View Citation
Funnell MM, Anderson RM. Patient empowerment: a look back, a look ahead. Diabetes Educ. 2003 May-Jun;29(3):454-8, 460, 462 passim. Review. — View Citation
Funnell MM, Brown TL, Childs BP, Haas LB, Hosey GM, Jensen B, Maryniuk M, Peyrot M, Piette JD, Reader D, Siminerio LM, Weinger K, Weiss MA. National Standards for diabetes self-management education. Diabetes Care. 2011 Jan;34 Suppl 1:S89-96. doi: 10.2337/dc11-S089. Review. — View Citation
Haas L, Maryniuk M, Beck J, Cox CE, Duker P, Edwards L, Fisher EB, Hanson L, Kent D, Kolb L, McLaughlin S, Orzeck E, Piette JD, Rhinehart AS, Rothman R, Sklaroff S, Tomky D, Youssef G; 2012 Standards Revision Task Force. National standards for diabetes self-management education and support. Diabetes Care. 2014 Jan;37 Suppl 1:S144-53. doi: 10.2337/dc14-S144. — View Citation
Hojat M, Gonnella J, Mangione S, Nasca T, Magee M. (2003). Physician empathy in medical education and practice: experience with The Jefferson Scale of Physician Empathy. Seminars in Integrative Medicine 2003; 1(1): 25-41.
Ingersoll GM, Marrero DG. A modified quality-of-life measure for youths: psychometric properties. Diabetes Educ. 1991 Mar-Apr;17(2):114-8. — View Citation
Marshall LE, Serran G, Cameron C. The Group Satisfaction Scale. Rockwood Psychological Services & Royal Ottawa Health Care Group - STU 2010.
Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002 Jul;25(7):1159-71. — View Citation
Pennebaker JW. Putting stress into words: health, linguistic, and therapeutic implications. Behav Res Ther. 1993 Jul;31(6):539-48. — View Citation
Rosal MC, Ockene IS, Restrepo A, White MJ, Borg A, Olendzki B, Scavron J, Candib L, Welch G, Reed G. Randomized trial of a literacy-sensitive, culturally tailored diabetes self-management intervention for low-income latinos: latinos en control. Diabetes Care. 2011 Apr;34(4):838-44. doi: 10.2337/dc10-1981. Epub 2011 Mar 4. — View Citation
Trento M, Gamba S, Gentile L, Grassi G, Miselli V, Morone G, Passera P, Tonutti L, Tomalino M, Bondonio P, Cavallo F, Porta M; ROMEO Investigators. Rethink Organization to iMprove Education and Outcomes (ROMEO): a multicenter randomized trial of lifestyle intervention by group care to manage type 2 diabetes. Diabetes Care. 2010 Apr;33(4):745-7. doi: 10.2337/dc09-2024. Epub 2010 Jan 26. — View Citation
Trento M, Passera P, Borgo E, Tomalino M, Bajardi M, Cavallo F, Porta M. A 5-year randomized controlled study of learning, problem solving ability, and quality of life modifications in people with type 2 diabetes managed by group care. Diabetes Care. 2004 Mar;27(3):670-5. — View Citation
Trento M, Tomelini M, Basile M, Borgo E, Passera P, Miselli V, Tomalino M, Cavallo F, Porta M. The locus of control in patients with Type 1 and Type 2 diabetes managed by individual and group care. Diabet Med. 2008 Jan;25(1):86-90. doi: 10.1111/j.1464-5491.2007.02319.x. — View Citation
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in hemoglobin A1c levels at 6 months | Hemoglobin A1c is measured in mmol/mol units. | Up to 6 months | |
Secondary | Change from baseline in weight at 6 months | Weight is measured in Kg. | Up to 6 months | |
Secondary | Change from baseline in fat mass at 6 months | Fat mass is measured in Kg/m2 | Up to 6 months | |
Secondary | Change from baseline in waist circumference at 6 months | Waist circumference is measured in cm | Up to 6 months | |
Secondary | Change from baseline in self-reported quality of life at 6 months | The Diabetes Quality of Life Questionnaire (DQOL) is a self-report scale to assess quality of life. This scale comprises 13 items that are grouped in 4 subscales: 1) satisfaction with treatment, 2) impact of treatment, 3) worry about the future effects of diabetes, and 4) worry about social/vocational issues. A total score may be also computed from the sum of the 13 items. Higher scores indicate poorer quality of life, ranging from 13 to 65. | Up to 6 months | |
Secondary | Change from baseline in self-reported locus of control at 6 months | Locus of control is measured using the Diabetes Specific Locus of Control Scale (DLOC), which is a self-report scale directed to diabetes patients. This scale comprises 13 items that are grouped in 3 subscales: 1) internal locus of control; 2) external locus of control; and 3) powerful other locus of control. Higher scores reflect higher locus of control in each of these dimensions. | Up to 6 months | |
Secondary | Change from baseline in self-reported empathy at 6 months | Empathy is measured using a questionnaire - Jefferson Scale of Physician Empathy (JSPE-R), which comprises 9 items. Self-reported empathy levels are measured through a total score that is derived from the sum of the 9 items. The total score range from 9 to 63, in which higher scores depict higher empathy levels. | Up to 6 months | |
Secondary | Change from baseline in self-reported group satisfaction at 6 months | Group satisfaction is measured using a questionnaire - Group Satisfaction Scale (GSS). The GSS assess 2 dimensions: 1) satisfaction with therapist subscale and 2) content/group process subscale. A total score may be also computed from the sum of the 12 items that comprise this scale. The scores range from 12 to 60, in which higher scores reflect higher satisfaction levels. | Up to 6 months | |
Secondary | Change from baseline in self-reported health | The 36-Item Short Form Survey is used to assess health perception. This scale comprises 36 items that are divided in 8 dimensions: 1) vitality; 2) physical functioning; 3) bodily pain; 4) general health perceptions; 5) physical role functioning; 6) emotional role functioning; 7) social role functioning; and 8) mental health. These subscales are transformed into a scale range from 0-100, in which lower scores indicate worse health perception. | Up to 6 months |
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