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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluating the Effectiveness of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03083795
• Other study ID #: Love&Support
• Status: Not yet recruiting
• Phase: N/A
• First received: March 14, 2017
• Last updated: March 17, 2017
• Start date: April 2017
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: BCDiabetes.Ca
• Contact: Thomas Elliott, MBBS
• Phone: 1-888-874-9333
• Email: tom.elliott[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Disease Progression
• Psychological Distress

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BCDiabetes.Ca

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1C	Hemoglobin A1C blood test	6 months post randomization
Primary	Diabetes distress	Score on Diabetes Distress Screening Scale	6 months post randomization
Primary	Self-reported social support	Score on Social Provisions Scale	6 months post randomization
Secondary	Blood pressure	Blood pressure	6 months post randomization
Secondary	Medical adherence	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	6 months post randomization
Secondary	Statin refusal	Participants will score yes (if they refuse statin treatment) or no (if they do not refuse statin treatment)	6 months post randomization
Secondary	Diet	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	6 months post randomization
Secondary	Exercise	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	6 months post randomization
Secondary	Weight	Weight will be recorded in kilograms	6 months post randomization