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

NCT03083795 | Unknown

• 1 other identifier: Love&Support
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Diabetes Mellitus, Type 2; Psychological Distress

Keywords

Social relationships; Vulnerable connections; Diabetes Distress; Support group

Outcome Measures

Primary Outcomes (3)

• A1C

  Hemoglobin A1C blood test

  6 months post randomization

• Diabetes distress

  Score on Diabetes Distress Screening Scale

  6 months post randomization

• Self-reported social support

  Score on Social Provisions Scale

  6 months post randomization

Secondary Outcomes (6)

• Blood pressure

  6 months post randomization

• Medical adherence

  6 months post randomization

• Statin refusal

  6 months post randomization

• Diet

  6 months post randomization

• Exercise

  6 months post randomization

Study Arms (2)

Social relationships intervention

EXPERIMENTAL

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

Control cohort

NO INTERVENTION

Patients in the control group will receive BC Diabetes standard care.

Interventions

Social relationships intervention BEHAVIORAL

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.

Social relationships intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• BCDiabetes.Ca: lead

Related Publications (12)

• 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.

  PMID: 20668659 BACKGROUND

• Byrne D, Alvaregna M editors. Handbook of Psychocardiology. 1st ed. New York: Springer; 2016.

  BACKGROUND

• 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. No abstract available.

  PMID: 25010529 BACKGROUND

• 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.

  PMID: 27344617 BACKGROUND

• 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.

  PMID: 22228744 BACKGROUND

• 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.

  PMID: 27566328 BACKGROUND

• 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. doi: 10.1016/S0140-6736(04)16202-8.

  PMID: 15145632 BACKGROUND

• 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. doi: 10.1186/1472-6963-6-124.

  PMID: 17018153 BACKGROUND

• O'Kane C, O'Kane D. Real: The Power of Authentic Connection. 1st ed. Clearmind publishing; 2016.

  BACKGROUND

• 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.

  PMID: 26049679 BACKGROUND

• Siousioura D. Review of therapeutic groups for type 1 diabetes mellitus patients. J Endocrinol Diabetes 2012;3(2):11-21.

  BACKGROUND

• 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. No abstract available.

  PMID: 27927693 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Elliott, MBBS

  BC Diabetes, The University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Elliott, MBBS

CONTACT

1-888-874-9333; tom.elliott@ubc.ca

Noren Z Khamis, BSc

CONTACT

1-604-369-6915; nkhamis@alumni.ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director at BC Diabetes

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: April 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 20, 2017

Record last verified: 2017-03