DiabetesCrewDNCT03678896
Creative Writing for Type 2 Diabetes Management
A study testing CrewD Program and Classical structured education in people with Diabetes, run by Associacao Protectora dos Diabeticos de Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetes
- What is being tested?
- CrewD Program and Classical structured education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2017to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only patients with type 2 diabetes of >1 year known duration, aged < 85 years were included in the intervention.
Who cannot join
- Patients that did not complete the four assessments.
About this study
Official title: Close Reading and Creative Writing - CrewD Program. An Alternative Educational Method for Group Care Intervention in Type 2 Diabetes Management. A Randomized Trial
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.
Read the detailed description
A structured educational model for type 2 diabetic patients using Group Care is currently being used in several institutions for help managing diabetes in these patients. In this study, this model was adjusted by introducing literary texts and using narrative skills. A randomized trial was designed to determine whether group dynamic strategies using narrative and reading produce the same positive outcomes as a conventional group approach. A total of 49 patients with type 2 Diabetes were randomized to two different Group Care dynamics, one "control group", with a classical structured educational approach and another, "intervention group", with close reading and creative writing. Evaluation included anthropometrical measures, A1c and questionnaires for psychological evaluation.
- Conditions
- Diabetes
- Being tested
- CrewD Program, Classical structured education
- Keywords
- Type II Diabetes, Educational methods, Disease self-management
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrewD ProgramBehavioural
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.
Classical structured educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Classical structured education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hemoglobin A1c levels at 6 months
Hemoglobin A1c is measured in mmol/mol units.
Measured: Up to 6 months
Secondary outcomes (8)
Change from baseline in weight at 6 months
Weight is measured in Kg.
Measured: Up to 6 months
Change from baseline in fat mass at 6 months
Fat mass is measured in Kg/m2
Measured: Up to 6 months
Change from baseline in waist circumference at 6 months
Waist circumference is measured in cm
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start5 Jan 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associacao Protectora dos Diabeticos de Portugal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- João Raposo, M.D., Study chair, Associacao Protectora dos Diabeticos de Portugal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678896
- Sponsor's protocol ID
- CrewD trial
- Acronym
- CrewD
- Status last verified
- Sep 2018
- First submitted
- 10 Sep 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24357210Chrvala 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.
PubMed 26658704Trento 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.
PubMed 20103547Trento 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.
PubMed 18199135Charon 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.
PubMed 26200577Pennebaker 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.
PubMed 8347112Frattaroli 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.
PubMed 17073523Ingersoll 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.
PubMed 1995281Ware 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.
PubMed 1593914Hojat 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.
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.
PubMed 3438399Marshall LE, Serran G, Cameron C. The Group Satisfaction Scale. Rockwood Psychological Services & Royal Ottawa Health Care Group - STU 2010.
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.
PubMed 21193633Funnell 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.
PubMed 12854337Rosal 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.
PubMed 21378213
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Close Reading and Creative Writing - CrewD Program. An Alternative Educational Method for Group Care Intervention in Type 2 Diabetes Management. A Randomized Trial
- ClinicalTrials.gov ID
- NCT03678896
- Acronym / sponsor ID
- CrewD / CrewD trial
- Conditions
- Diabetes
- Keywords
- Type II Diabetes, Educational methods, Disease self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Associacao Protectora dos Diabeticos de PortugalUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A structured educational model for type 2 diabetic patients using Group Care is currently being used in several institutions for help managing diabetes in these patients. In this study, this model was adjusted by introducing literary texts and using narrative skills. A randomized trial was designed to determine whether group dynamic strategies using narrative and reading produce the same positive outcomes as a conventional group approach. A total of 49 patients with type 2 Diabetes were randomized to two different Group Care dynamics, one "control group", with a classical structured educational approach and another, "intervention group", with close reading and creative writing. Evaluation included anthropometrical measures, A1c and questionnaires for psychological evaluation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CrewD Program approach | Experimental | Behavioral: CrewD ProgramThe 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. |
| Classical structured education | Active comparator | Behavioral: Classical structured educationEach 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only patients with type 2 diabetes of >1 year known duration, aged < 85 years were included in the intervention.
Key exclusion criteria (1 listed)
- Patients that did not complete the four assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrewD ProgramThe 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. | Behavioural | CrewD Program approach |
| Classical structured educationThe 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. | Behavioural | Classical structured education |
Primary outcome
Change from baseline in hemoglobin A1c levels at 6 months
Time frame: Up to 6 months
Hemoglobin A1c is measured in mmol/mol units.
8 secondary outcomes
Change from baseline in weight at 6 months
Time frame: Up to 6 months
Change from baseline in fat mass at 6 months
Time frame: Up to 6 months
Change from baseline in waist circumference at 6 months
Time frame: Up to 6 months
Change from baseline in self-reported quality of life at 6 months
Time frame: Up to 6 months
Change from baseline in self-reported locus of control at 6 months
Time frame: Up to 6 months
Change from baseline in self-reported empathy at 6 months
Time frame: Up to 6 months
Change from baseline in self-reported group satisfaction at 6 months
Time frame: Up to 6 months
Change from baseline in self-reported health
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Background: PubMed 24357210Haas 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.
- Background: PubMed 26658704Chrvala 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.
- Background: PubMed 20103547Trento 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.
- Background: PubMed 18199135Trento 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.
- Background: PubMed 26200577Charon 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.
- Background: PubMed 8347112Pennebaker 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.
- Background: PubMed 17073523Frattaroli 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.
- Background: PubMed 1995281Ingersoll 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.
- Background: PubMed 1593914Ware 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.
- BackgroundHojat 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: PubMed 3438399Ferraro 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.
- BackgroundMarshall LE, Serran G, Cameron C. The Group Satisfaction Scale. Rockwood Psychological Services & Royal Ottawa Health Care Group - STU 2010.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
João Raposo, M.D. study chair
Associacao Protectora dos Diabeticos de Portugal
Questions about this trial
What is this clinical trial studying?
A study testing CrewD Program and Classical structured education in people with Diabetes, run by Associacao Protectora dos Diabeticos de Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hemoglobin A1c levels at 6 months (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03678896, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2018.