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The Effect of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes

This study is not yet open for participant recruitment.
Verified March 2017 by Tom Elliott, BCDiabetes.Ca
Sponsor:
ClinicalTrials.gov Identifier:
NCT03083795
First Posted: March 20, 2017
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Tom Elliott, BCDiabetes.Ca
  Purpose
This study will determine the feasibility and effectiveness of a monthly social support group along with a weekly peer-to-peer meeting in improving perceived level of social support, diabetes distress, and A1c profiles in patients with Type II diabetes mellitus, compared with standard care offered at British Columbia Diabetes (BC Diabetes).

Condition Intervention
Diabetes Mellitus, Type 2 Psychological Distress Behavioral: Social relationships intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants randomized to the social interaction cohort will meet on a monthly basis for a two hour group session designed to build social connections. In addition, participants will be paired with another study participant in this group, and will be asked to meet on a monthly basis for a minimum of 45 minutes. All participants in the social support cohort will continue to receive best standard diabetes management.

Participants in the control group will be treated with standard diabetes care.

Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluating the Effectiveness of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes: A Randomized Controlled Trial

Further study details as provided by Tom Elliott, BCDiabetes.Ca:

Primary Outcome Measures:
  • A1C [ Time Frame: 6 months post randomization ]
    Hemoglobin A1C blood test

  • Diabetes distress [ Time Frame: 6 months post randomization ]
    Score on Diabetes Distress Screening Scale

  • Self-reported social support [ Time Frame: 6 months post randomization ]
    Score on Social Provisions Scale


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 6 months post randomization ]
    Blood pressure

  • Medical adherence [ Time Frame: 6 months post randomization ]
    Participants will indicate their level of medication adherence on a scale of 1-5. To do this, they will respond to the question "To what extent do you agree with the following statement: I reliably take my diabetes-related medication", where the possible responses are: strongly disagree, disagree, neutral, agree, strongly agree. These responses will be converted into a 5-point scale where strongly disagree = 1 and strongly agree = 5

  • Statin refusal [ Time Frame: 6 months post randomization ]
    Participants will score yes (if they refuse statin treatment) or no (if they do not refuse statin treatment)

  • Diet [ Time Frame: 6 months post randomization ]
    Participants will score their diet on a scale of 1-5. To do this, they will respond to the question " I currently have a good diet", where the possible responses are: strongly disagree, disagree, neutral, agree, strongly agree. These responses will be converted into a 5-point scale where strongly disagree = 1 and strongly agree = 5

  • Exercise [ Time Frame: 6 months post randomization ]
    Participants will score their exercise on a scale of 1-5. To do this, they will respond to the question "I currently get enough exercise", where the possible responses are: strongly disagree, disagree, neutral, agree, strongly agree. These responses will be converted into a 5-point scale where strongly disagree = 1 and strongly agree = 5

  • Weight [ Time Frame: 6 months post randomization ]
    Weight will be recorded in kilograms


Estimated Enrollment: 48
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Social relationships intervention

Participants randomized to the social interaction cohort will be split into two groups of 12. Each group of 12 will meet together once a month for a two-hour support group. Each participant will be allowed five minutes to "check-in" with the support group. During the 5 minute period the participant is encouraged to share their innermost thoughts and feelings in the knowledge that this information will not be shared outside the group.

Participants will additionally be paired with another study participant in the same cohort and will be asked to meet outside group sessions once a week for a minimum of 45 minutes. The pairing process will take place by study investigators and will be sensitive to gender, age, and neighbourhood of residence. Participants who find that their paired partner is not suitable may ask the facilitators to help find a more suitable match.

These participants will continue to receive BC Diabetes standard care.

Behavioral: Social relationships intervention
Participants randomized to the social interaction cohort will meet on a monthly basis for a two hour group session designed to build social connections. In addition, participants will be paired with another study participant in this group, and will be asked to meet on a monthly basis for a minimum of 45 minutes. All participants in the social support cohort will continue to receive best standard diabetes management.
No Intervention: Control cohort
Patients in the control group will receive BC Diabetes standard care.

Detailed Description:

This is a prospective, randomized, non-blinded comparative group clinical trial of 48 participants receiving social interaction in addition to standard diabetes care or standard diabetes care alone. All participants will have a baseline and 6 month follow-up visit where assessment of their A1C, diabetes distress, and social support will be performed.

Participants randomized to the social interaction cohort will meet on a monthly basis for a two hour group session designed to build social connections. In addition, participants will be paired with another study participant in this group, and will be asked to meet on a monthly basis for a minimum of 45 minutes. All participants in the social support cohort will continue to receive best standard diabetes management.

Participants in the control group will be treated with standard diabetes care. At the end of the 6-month study, they will have the opportunity to engage in the same social interventions offered to the social interaction group.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willingly provide your full informed consent to participate;
  • Are at least 19 years of age;
  • Have an established diagnosis of Type 2 diabetes mellitus;
  • Have a Diabetes Distress Screening Scale (a score of 2-3 is considered moderate distress, 3-4 is considered high)
  • Have a Social Provisions Scale score less than 60 (a score of 80-90 is considered high, 60-80 moderate and less than 60 sub-optimal)
  • Have an A1c greater than 8.5% in the last 2 months (a score of 6-7 is considered optimal, 7-8 sub-optimal and >8.0 inadequate)

Exclusion Criteria:

  • Are unable to easily communicate in oral and written English.
  • Have a physical disability or psychiatric diagnosis which would limit the ability to participate in the study;
  • Are a prisoner, or in pre-trial;
  • Do not have a fixed address;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03083795


Contacts
Contact: Thomas Elliott, MBBS 1-888-874-9333 tom.elliott@ubc.ca
Contact: Noren Z Khamis, BSc 1-604-369-6915 nkhamis@alumni.ubc.ca

Sponsors and Collaborators
BCDiabetes.Ca
Investigators
Principal Investigator: Thomas Elliott, MBBS BC Diabetes, The University of British Columbia
  More Information

Publications:
Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316. Review.
Byrne D, Alvaregna M editors. Handbook of Psychocardiology. 1st ed. New York: Springer; 2016.
Ducat L, Philipson LH, Anderson BJ. The mental health comorbidities of diabetes. JAMA. 2014 Aug 20;312(7):691-2. doi: 10.1001/jama.2014.8040.
Feng X, Astell-Burt T. What types of social interactions reduce the risk of psychological distress? Fixed effects longitudinal analysis of a cohort of 30,271 middle-to-older aged Australians. J Affect Disord. 2016 Nov 1;204:99-102. doi: 10.1016/j.jad.2016.06.041. Epub 2016 Jun 14.
Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6.
Hackett RA, Steptoe A. Psychosocial Factors in Diabetes and Cardiovascular Risk. Curr Cardiol Rep. 2016 Oct;18(10):95. doi: 10.1007/s11886-016-0771-4. Review.
Ismail K, Winkley K, Rabe-Hesketh S. Systematic review and meta-analysis of randomised controlled trials of psychological interventions to improve glycaemic control in patients with type 2 diabetes. Lancet. 2004 May 15;363(9421):1589-97. Review.
Rabi DM, Edwards AL, Southern DA, Svenson LW, Sargious PM, Norton P, Larsen ET, Ghali WA. Association of socio-economic status with diabetes prevalence and utilization of diabetes care services. BMC Health Serv Res. 2006 Oct 3;6:124.
O'Kane C, O'Kane D. Real: The Power of Authentic Connection. 1st ed. Clearmind publishing; 2016.
Rossi MC, Lucisano G, Funnell M, Pintaudi B, Bulotta A, Gentile S, Scardapane M, Skovlund SE, Vespasiani G, Nicolucci A; BENCH-D Study Group. Interplay among patient empowerment and clinical and person-centered outcomes in type 2 diabetes. The BENCH-D study. Patient Educ Couns. 2015 Sep;98(9):1142-9. doi: 10.1016/j.pec.2015.05.012. Epub 2015 May 21.
Siousioura D. Review of therapeutic groups for type 1 diabetes mellitus patients. J Endocrinol Diabetes 2012;3(2):11-21.
Young-Hyman D, de Groot M, Hill-Briggs F, Gonzalez JS, Hood K, Peyrot M. Erratum. Psychosocial Care for People With Diabetes: A Position Statement of the American Diabetes Association. Diabetes Care 2016;39:2126-2140. Diabetes Care. 2017 Feb;40(2):287. doi: 10.2337/dc17-er02. Epub 2016 Dec 7.

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Study protocol
Informed Consent Form  This link exits the ClinicalTrials.gov site
Informed consent form

Responsible Party: Tom Elliott, Medical Director at BC Diabetes, BCDiabetes.Ca
ClinicalTrials.gov Identifier: NCT03083795     History of Changes
Other Study ID Numbers: Love&Support
First Submitted: March 14, 2017
First Posted: March 20, 2017
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At the end of the study, anonymized participant data may be shared with other researchers wishing to undergo similar studies to assist with study design and implementation.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tom Elliott, BCDiabetes.Ca:
Social relationships
Vulnerable connections
Diabetes Distress
Support group

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Disease Progression
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Disease Attributes
Pathologic Processes


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