Creative Writing for Type 2 Diabetes Management

NCT03678896 | Completed

• 1 other identifier: CrewD trial
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes

Keywords

Type II Diabetes; Educational methods; Disease self-management

Outcome Measures

Primary Outcomes (1)

• Change from baseline in hemoglobin A1c levels at 6 months

  Hemoglobin A1c is measured in mmol/mol units.

  Up to 6 months

Secondary Outcomes (8)

• Change from baseline in weight at 6 months

  Up to 6 months

• Change from baseline in fat mass at 6 months

  Up to 6 months

• Change from baseline in waist circumference at 6 months

  Up to 6 months

• Change from baseline in self-reported quality of life at 6 months

  Up to 6 months

• Change from baseline in self-reported locus of control at 6 months

  Up to 6 months

Study Arms (2)

CrewD Program approach

EXPERIMENTAL

The aim was to increase education about the disease by using narrative skills through the CrewD Program. The sessions were conducted by two group leaders: a health professional and a literature professor manager of creative writing groups. Each session had a title, which parallels the classical structured educational approach (active comparator condition), which was known in advance by the subjects: a) Who I am in Diabetes?; b) Nutrition; c) The body where I live; d) Fears; e) Can attention change things?; and f) Roots. Team leaders directed a discussion of different texts used in the sessions with the participants focusing on their feelings and on how the texts relate to themselves and to their diabetes. Patients were encouraged to participate and freely express their opinion.

Behavioral: CrewD Program

Classical structured education

ACTIVE COMPARATOR

Each session was 90 minutes long, with a similar internal structure in all of them. Each session included the following topics: a) Chronic Disease; b) Nutrition; c) Exercise; d) Complications; e) Self-management; and f) Diabetic foot. The sessions were held in a large room, in which the seats were arranged in circle. Every session was chaired by two healthcare providers, who worked as group leaders. There was a different visual presentation in each session, with relevant theoretical information. A board with sheets of paper was available for use in the discussion along with brochures about the disease. Patients were encouraged to actively participate and take part in group-problem solving. Group leaders guided the discussion by asking questions and encouraging the discussion.

Behavioral: Classical structured education

Interventions

CrewD Program BEHAVIORAL

The CrewD Program - Creative reading and writing in Diabetes Program - is a Diabetes self-management education and support program to help people with Diabetes coping with the disease.

CrewD Program approach

Classical structured education BEHAVIORAL

The Classical educational approach consists in an educational method based on the presentation of relevant theoretical information to help people with Diabetes coping with the disease.

Classical structured education

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only patients with type 2 diabetes of \>1 year known duration, aged \< 85 years were included in the intervention.

You may not qualify if:

• Patients that did not complete the four assessments.

Sponsors & Collaborators

• Associacao Protectora dos Diabeticos de Portugal: lead

Related Publications (17)

• 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(Suppl 1):S144-53. doi: 10.2337/dc14-S144. No abstract available.

  PMID: 24357210 BACKGROUND

• 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.

  PMID: 26658704 BACKGROUND

• 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.

  PMID: 20103547 BACKGROUND

• 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.

  PMID: 18199135 BACKGROUND

• 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.

  PMID: 26200577 BACKGROUND

• Pennebaker JW. Putting stress into words: health, linguistic, and therapeutic implications. Behav Res Ther. 1993 Jul;31(6):539-48. doi: 10.1016/0005-7967(93)90105-4.

  PMID: 8347112 BACKGROUND

• Frattaroli J. Experimental disclosure and its moderators: a meta-analysis. Psychol Bull. 2006 Nov;132(6):823-65. doi: 10.1037/0033-2909.132.6.823.

  PMID: 17073523 BACKGROUND

• Ingersoll GM, Marrero DG. A modified quality-of-life measure for youths: psychometric properties. Diabetes Educ. 1991 Mar-Apr;17(2):114-8. doi: 10.1177/014572179101700219.

  PMID: 1995281 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  BACKGROUND

• Ferraro LA, Price JH, Desmond SM, Roberts SM. Development of a diabetes locus of control scale. Psychol Rep. 1987 Dec;61(3):763-70. doi: 10.2466/pr0.1987.61.3.763. No abstract available.

  PMID: 3438399 BACKGROUND

• Marshall LE, Serran G, Cameron C. The Group Satisfaction Scale. Rockwood Psychological Services & Royal Ottawa Health Care Group - STU 2010.

  BACKGROUND

• 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(Suppl 1):S89-96. doi: 10.2337/dc11-S089. No abstract available.

  PMID: 21193633 BACKGROUND

• Funnell MM, Anderson RM. Patient empowerment: a look back, a look ahead. Diabetes Educ. 2003 May-Jun;29(3):454-8, 460, 462 passim. doi: 10.1177/014572170302900310. No abstract available.

  PMID: 12854337 BACKGROUND

• 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.

  PMID: 21378213 BACKGROUND

• 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. doi: 10.2337/diacare.25.7.1159.

  PMID: 12087014 BACKGROUND

• 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. doi: 10.2337/diacare.27.3.670.

  PMID: 14988283 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• João Raposo, M.D.

  Associacao Protectora dos Diabeticos de Portugal

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 20, 2018
• Study Start: January 5, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: September 20, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share