The Effect of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes
Evaluating the Effectiveness of Social Relationships on Psychological Distress and Disease Progression in Patients With Diabetes: A Randomized Controlled Trial
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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;
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
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.
|
|
介入なし：Control cohort
Patients in the control group will receive BC Diabetes standard care.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
A1C
時間枠：6 months post randomization
|
Hemoglobin A1C blood test
|
6 months post randomization
|
|
Diabetes distress
時間枠：6 months post randomization
|
Score on Diabetes Distress Screening Scale
|
6 months post randomization
|
|
Self-reported social support
時間枠：6 months post randomization
|
Score on Social Provisions Scale
|
6 months post randomization
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood pressure
時間枠：6 months post randomization
|
Blood pressure
|
6 months post randomization
|
|
Medical adherence
時間枠：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
|
6 months post randomization
|
|
Statin refusal
時間枠：6 months post randomization
|
Participants will score yes (if they refuse statin treatment) or no (if they do not refuse statin treatment)
|
6 months post randomization
|
|
Diet
時間枠：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
|
6 months post randomization
|
|
Exercise
時間枠：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
|
6 months post randomization
|
|
Weight
時間枠：6 months post randomization
|
Weight will be recorded in kilograms
|
6 months post randomization
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Thomas Elliott, MBBS、BC Diabetes, The University of British Columbia
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. No abstract available.
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- Love&Support
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
試験データ・資料
-
インフォームド コンセント フォーム
情報コメント：Informed consent form
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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