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Diabetes Mellitus, Type 2NCT03083795

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

A study testing Social relationships intervention in people with Diabetes Mellitus, Type 2 and Psychological Distress, run by BCDiabetes.Ca.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Social relationships intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
Apr 2017to Dec 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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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;

Trial locations and contacts

No sites are listed yet.

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

About this study

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

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).

Read the 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.

Being tested
Social relationships intervention
Keywords
Social relationships, Vulnerable connections, Diabetes Distress, Support group
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social relationships interventionBehavioural

    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.

Study groups in NCT03083795
Study groupRoleWhat they receive
Social relationships interventionExperimentalParticipants 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.
Receives: Behavioral: Social relationships intervention
Control cohortNo interventionPatients in the control group will receive BC Diabetes standard care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A1C

    Hemoglobin A1C blood test

    Measured: 6 months post randomization

  2. Diabetes distress

    Score on Diabetes Distress Screening Scale

    Measured: 6 months post randomization

  3. Self-reported social support

    Score on Social Provisions Scale

    Measured: 6 months post randomization

Secondary outcomes (6)

  1. Blood pressure

    Blood pressure

    Measured: 6 months post randomization

  2. 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

    Measured: 6 months post randomization

  3. Statin refusal

    Participants will score yes (if they refuse statin treatment) or no (if they do not refuse statin treatment)

    Measured: 6 months post randomization

  4. 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

    Measured: 6 months post randomization

  5. 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

    Measured: 6 months post randomization

  6. Weight

    Weight will be recorded in kilograms

    Measured: 6 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2017
  2. Study startApr 2017 (estimated)
  3. Primary completionOct 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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
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 blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03083795
Sponsor's protocol ID
Love&Support
Status last verified
Mar 2017
First submitted
14 Mar 2017
Last updated
20 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

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.

    PubMed 20668659

  • 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. No abstract available.

    PubMed 25010529

  • 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.

    PubMed 27344617

  • 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.

    PubMed 22228744

  • 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.

    PubMed 27566328

  • 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.

    PubMed 15145632

  • 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.

    PubMed 17018153

  • 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.

    PubMed 26049679

  • 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. No abstract available.

    PubMed 27927693

Questions about this trial

What is this clinical trial studying?

A study testing Social relationships intervention in people with Diabetes Mellitus, Type 2 and Psychological Distress, run by BCDiabetes.Ca.

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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Mar 2017. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Thomas Elliott, MBBS (1-888-874-9333, tom.elliott@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A1C (time frame: 6 months post randomization). The study lists 3 primary outcomes in all. 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 NCT03083795, which also lists 12 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 Mar 2017.

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