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BMC Geriatrics
Published in: BMC Geriatrics 1/2020

Open Access 01-12-2020 | Diabetes | Study protocol

Couple-based collaborative management model of type 2 diabetes mellitus for community-dwelling older adults in China: protocol for a hybrid type 1 randomized controlled trial

Authors: Jing Liao, Xueji Wu, Caixuan Wang, Xiaochun Xiao, Yiyuan Cai, Min Wu, Yuyang Liu, Xiongfei Chen, Shaolong Wu, Yung Jen Yang, Dong (Roman) Xu

Published in: BMC Geriatrics | Issue 1/2020

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Abstract

Background

China’s limited health care resources cannot meet the needs of chronic disease treatment and management of its rapid growing ageing population. The improvement and maintenance of patient’s self-management is essential to disease management. Given disease management mainly occurs in the context of family, this study proposes to validate a Couple-based Collaborative Management Model of chronic diseases that integrates health professionals and family supporters; such as to empower the couples with disease management knowledge and skills, and to improve the couples’ health and quality of life.

Methods

The proposed study will validate a couple-based collaborative management model of Type 2 Diabetes Mellitus (T2DM) in a community-based multicenter, two-arm, randomized controlled trial of block design in Guangzhou, China. Specifically, 194 T2DM patients aged ≥55 and their partners recruited from community health care centers will be randomized at the patient level for each center at a 1:1 ratio into the couple-based intervention arm and the individual-based control arm. For the intervention arm, both the patients and their spouses will receive four-weekly structured group education & training sessions and 2 months of weekly tailored behavior change boosters; while these interventions will be only provided to the patients in the control group. Behavior change incentives will be targeted at the couples or only at the patient respectively. Treatment effects on patients’ hemoglobin, spouses’ quality of life, alongside couples’ behavior outcomes will be compared between arms. Study implementation will be evaluated considering its Reach, Effectiveness, Adoption, Implementation and Maintenance following the RE-AIM framework.

Discussion

This study will generate a model of effective collaboration between community health professionals and patients’ family, which will shield light on chronic disease management strategy for the increasing ageing population.

Trial registration

Chinese Clinical Trial Registry, ChiCTR1900027137​, Registered 1st Nov. 2019
Appendix
Available only for authorised users
Literature
1.
2.
Caiyou W, Qun M, Ling X, Yude C. An analysis report of national health services survey in China (2013). Beijing: Center for Health Statistics and Information; 2015.
3.
Wang L, Gao P, Zhang M, Huang Z, Zhang D, Deng Q, et al. Prevalence and ethnic pattern of diabetes and Prediabetes in China in 2013. JAMA. 2017;317(24):2515.PubMedPubMedCentralCrossRef
4.
Xiaoli Z. Current problems and thinking in the management of chronic diseases in the elderly in our community. Community Med J. 2017;15(17):80–1.
5.
Ping T, Jianqun D. Progress in self-management of diabetic patients. Prev Control Chronic Dis China. 2011;19(4):435–9.
6.
7.
Toukhsati SR, Hare LD. Towards optimal heart failure care: couples-oriented strategies to improve patient adherence and health outcomes. Curr Cardiol Rev. 2016;12(3):243–8.PubMedPubMedCentralCrossRef
8.
Dimatteo MR. Social support and patient adherence to medical treatment: a meta-analysis. Health Psychol. 2004;23(2):207–18.PubMedCrossRef
9.
Liao J, Brunner EJ. Structural and functional measures of social relationships and quality of life among older adults: does chronic disease status matter? Qual Life Res. 2016;25(1):153–64.PubMedCrossRef
10.
11.
Berg CA, Upchurch R. A developmental-contextual model of couples coping with chronic illness across the adult life span. Psychol Bull. 2007;133(6):920–54.PubMedCrossRef
12.
13.
Helgeson VS, Jakubiak B, Van MV, Zajdel M. Communal coping and adjustment to chronic illness: theory update and evidence. Pers Soc Psychol Rev. 2017;1:108886831773576.
14.
Vassilev I, Rogers A, Kennedy A, Koetsenruijter J. The influence of social networks on self-management support: a metasynthesis. BMC Public Health. 2014;14(1):719.PubMedPubMedCentralCrossRef
15.
Martire LM, Schulz R, Helgeson VS, Small BJ, Saghafi EM. Review and meta-analysis of couple-oriented interventions for chronic illness. Ann Behav Med. 2010;40(3):325–42.PubMedCrossRef
16.
Stahl ST, Rodakowski J, Saghafi EM, Park M, Reynolds CF, Dew MA. Systematic review of dyadic and family-oriented interventions for late-life depression. Int J Geriatr Psychiatry. 2016;31(9):963–73.PubMedPubMedCentralCrossRef
17.
Martire LM, Lustig AP, Schulz R, Miller GE, Helgeson VS. Is it beneficial to involve a family member? A meta-analysis of psychosocial interventions for chronic illness. Health Psychol. 2004;23(6):599.PubMedCrossRef
18.
Voils CI, Coffman CJ, Yancy WS Jr, Weinberger M, Jeffreys AS, Datta S, et al. A randomized controlled trial to evaluate the effectiveness of CouPLES: a spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol. Prev Med. 2013;56(1):46–52.PubMedCrossRef
19.
Gorin AA, Wing RR, Fava JL, Jakicic JM, Jeffery R, West DS, et al. Weight loss treatment influences untreated spouses and the home environment: evidence of a ripple effect. Int J Obes. 2008;32(11):1678–84.CrossRef
20.
Trief PM, Fisher L, Sandberg J, Cibula DA, Dimmock J, Hessler DM, et al. Health and psychosocial outcomes of a telephonic couples behavior change intervention in patients with poorly controlled type 2 diabetes: a randomized clinical trial. Diabetes Care. 2016;39(12):2165–73.PubMedPubMedCentralCrossRef
21.
Trief PM, Fisher L, Sandberg J, Hessler DM, Cibula DA, Weinstock RS. Two for one? Effects of a couples intervention on partners of persons with type 2 diabetes: a randomized controlled trial. Diabet Med. 2018;36:473–81.
22.
Wing RR, Marcus MD, Epstein LH, Jawad A. A “family-based” approach to the treatment of obese type II diabetic patients. J Consult Clin Psychol. 1991;59(1):156.PubMedCrossRef
23.
Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of. Diabetes. 2009;32(1):193–203.
24.
Little RR, Rohlfing CL, Sacks DB. Status of hemoglobin A1c measurement and goals for improvement: from chaos to order for improving diabetes care. Clin Chem. 2011;57(2):205–14.PubMedCrossRef
25.
Tang TS, Funnell M, Sinco B, Piatt G, Palmisano G, Spencer MS, et al. Comparative effectiveness of peer leaders and community health workers in diabetes self-management support: results of a randomized controlled trial. Diabetes Care. 2014;37(6):1525–34.PubMedPubMedCentralCrossRef
26.
Beverly EA, Miller CK, Wray LA. Spousal support and food-related behavior change in middle-aged and older adults living with type 2 diabetes. Health Educ Behav. 2007;35(5):707–20.PubMedCrossRef
27.
Jing D, Zhaoxia G. Application of couple-centered psychological intervention on in nursing Care of Elderly Patients with type 2 diabetes mellitus. Nurs J Chinese Peoples Liberation Army. 2018;35(4):70–3.
28.
Wooldridge JS. A couples-based approach for increasing physical activity among couples with type 2 diabetes. Denver: University of Colorado; 2017.
29.
Brown H, Prescott R. Applied mixed models in medicine 2nd ed 28. Chichester, West Sussex, England: John Wiley & Sons ltd. applied mixed models in medicine 2nd ed 28. Chichester: Wiley; 2006.CrossRef
30.
Prestwich A, Conner MT, Lawton RJ, Ward JK, Ayres K, Mceachan RRC. Randomized controlled trial of collaborative implementation intentions targeting working adults’ physical activity. Health Psychol. 2012;31(31):486–95.PubMedCrossRef
31.
Yeling L, Mingzi L, Hua J, Lei L, Yingying L, Jingjing S, et al. Preliminary practice of non-insulin therapy for structured therapy and education curriculum development in patients with type 2 diabetes. Chinese J Diab. 2016;24(7):638–44.
32.
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81–95.PubMedCrossRef
33.
Morton K, Sutton S, Hardeman W, Troughton J, Yates T, Griffin S, et al. A text-messaging and pedometer program to promote physical activity in people at high risk of type 2 diabetes: the development of the PROPELS follow-on support program. Jmir Mhealth Uhealth. 2015;3(4):e105.PubMedPubMedCentralCrossRef
34.
Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Heuer J, et al. Framing financial incentives to increase physical activity among overweight and obese adults: a randomized, controlled trial. Ann Intern Med. 2016;164(6):385–94.PubMedPubMedCentralCrossRef
35.
Patel MS, Asch DA, Rosin R, Small DS, Bellamy SL, Eberbach K, et al. Individual versus team-based financial incentives to increase physical activity: a randomized, controlled trial. J Gen Intern Med. 2016;31(7):746–54.PubMedPubMedCentralCrossRef
36.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81.PubMedCrossRef
37.
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019;95:103208.PubMedPubMedCentralCrossRef
38.
Ware J, Snoww K, Ma K, Bg G. SF36 Health Survey: Manual and Interpretation Guide; 1993.
39.
Ling W, Xiaodan W, Yumei L, Guihong F, Hong Z. The SF_36 scale is used for the reliability and validity of the elderly. Chin J Gerontol. 2008;28(11):1114–5.
40.
Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000;23(7):943–50.CrossRefPubMed
41.
Huan ZW. Validation of the reliability and validity of the Chinese version of diabetes self-management behavior scale. Chin J Nurs. 2014;16:5–8.
42.
Svarstad BL, Chewning BA, Sleath BL, Claesson C. The brief medication questionnaire: a tool for screening patient adherence and barriers to adherence. Patient Educ Couns. 1999;37(2):113–24.PubMedCrossRef
43.
Booth MJRqfe, sport. Assessment of physical activity: an international perspective. 2000;71(sup2):114–20.
44.
Deng HB, Macfarlane DJ, Thomas GN, Lao XQ, Jiang CQ, Cheng KK, et al. Reliability and validity of the IPAQ-Chinese: the Guangzhou biobank cohort study. Med Sci Sports Exerc. 2008;40(2):303–7.PubMedCrossRef
45.
Wang Limin ZM, Yuchong L, Zhengjing H, Wei D, Zhenping Z, et al. overall plan for monitoring chronic diseases and their risk factors in China in 2013. Chinese J Prev Med. 2018;52(2):191–4.
46.
Rifas-Shiman SL, Willett WC, Lobb R, Kotch J, Dart C, Gillman MW. PrimeScreen, a brief dietary screening tool: reproducibility and comparability with both a longer food frequency questionnaire and biomarkers. Public Health Nutr. 2001;4(2):249–54.PubMedCrossRef
47.
Wan Qiaoqin SS. Reliability and validity of diabetes self-efficacy energy meter. Nurs Res. 2009;23(17):1589–90.
48.
Wichit N, Mnatzaganian G, Courtney M, Schulz P, Johnson M. Psychometric testing of the family-Carer diabetes management self-efficacy scale. Health Soc Care Community. 2018;26(2):214–23.PubMedCrossRef
49.
Helgeson VS, Berg CA, Kelly CS, Van Vleet M, Zajdel M, Tracy EL, et al. Patient and partner illness appraisals and health among adults with type 1 diabetes. J Behav Med. 2019;42(3):480–92.PubMedCrossRef
50.
Stephens MAP, Franks MM, Rook KS, Masumi I, Hemphill RC, Salem JK. Spouses’ attempts to regulate day-to-day dietary adherence among patients with type 2 diabetes. Health Psychol. 2013;32(10):1029–37.PubMedCrossRef
51.
Sullivan TR, White IR, Salter AB, Ryan P, Lee KJ. Should multiple imputation be the method of choice for handling missing data in randomized trials? Stat Methods Med Res. 2018;27(9):2610–26.PubMedCrossRef
52.
Harden SM, Smith ML, Ory MG, Smith-Ray RL, Estabrooks PA, Glasgow RE. Re-aim in clinical, community, and corporate settings: perspectives, strategies, and recommendations to enhance public health impact. Front Public Health. 2018;6:71.PubMedPubMedCentralCrossRef
53.
Glasgow RE, Estabrooks PE. Pragmatic Applications of RE-AIM for Health Care Initiatives in Community and Clinical Settings. Prev Chronic Dis. 2018;15(1):170271.CrossRef
Metadata
Title
Couple-based collaborative management model of type 2 diabetes mellitus for community-dwelling older adults in China: protocol for a hybrid type 1 randomized controlled trial
Authors
Jing Liao
Xueji Wu
Caixuan Wang
Xiaochun Xiao
Yiyuan Cai
Min Wu
Yuyang Liu
Xiongfei Chen
Shaolong Wu
Yung Jen Yang
Dong (Roman) Xu
Publication date
01-12-2020
Publisher
BioMed Central
Published in
BMC Geriatrics / Issue 1/2020
Electronic ISSN: 1471-2318
DOI
https://doi.org/10.1186/s12877-020-01528-5

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