Dataset Information

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.

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.

SUBMITTER: Liao J

PROVIDER: S-EPMC7106607 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Publications

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.

Liao Jing J Wu Xueji X Wang Caixuan C Xiao Xiaochun X Cai Yiyuan Y Wu Min M Liu Yuyang Y Chen Xiongfei X Wu Shaolong S Yang Yung Jen YJ Xu Dong Roman DR

BMC geriatrics 20200330 1

<h4>Background</h4>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 empowe ...[more]

PMID: 32228462

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Project description:Background: To mobilize family's positive involvement in improving and sustaining self-management activities of older adults with diabetes, we developed a couple-based collaborative management model (CCMM) for community-dwelling older Chinese. Methods: The model was developed stepwise through applying theoretical models, interviewing older couples and community healthcare workers, as well as incorporating expert reviews. A 3-month pilot study was conducted to test the model's feasibility and its treatment effects by linear regression on 18 pairs of older couples aged 60 years+, who were equally divided into a couple-based intervention arm and a patient-only control arm. Results: The developed CCMM covered four theory-driven intervention modules: dyadic assessment, dyadic education, dyadic behavior-change training, and dyadic monitoring. Each module was delivered by community healthcare workers and targeted at older couples as the management units. Based on interviews with older couples and healthcare workers, 4 weekly education and training group sessions and 2-month weekly behavior change booster calls were designed to address older adults' main management barriers. These modules and session contents were evaluated as essential and relevant by the expert panel. Furthermore, the CCMM showed good feasibility and acceptability in the pilot, with non-significant yet more positive changes in physiological outcomes of diabetic participants and couples' well-being and exercise levels of these in the intervention arm than their controlled counterparts. Conclusion: We systematically developed a couple-based collaborative management model of diabetes, which was well-received by healthcare practitioners and highly feasible among older Chinese couples living in the community. The model's treatment effects need to be verified in fully powered randomized controlled trials. Clinical Trial Registration: http://www.chictr.org.cn/showproj.aspx?proj=42964, identifier: ChiCTR1900027137.

Project description:BackgroundDiabetes mellitus is a prevalent and potentially devastating chronic illness affecting many older adults. Given spousal involvement in many aspects of diabetes management, coping with their partners is increasingly seen as a potential solution to make up for limited resources. This study aimed to identify the key conditions for optimal implementation of couple-based collaborative management model (CCMM) among Chinese older couples with type 2 diabetes mellitus.MethodsOlder couples and community healthcare practitioners were selected according to couples' joint intervention attendance rate and community's average attendance rate. This mixed methods research consisted of a qualitative phase and a quantitative phase. In the qualitative phase, in-depth interviews were conducted among 12 pairs of couples in the intervention group and 4 corresponding practitioners, in the follow-up period of the multicentered RCT from January to April 2022. Qualitative comparative analysis (QCA) in the quantitative phase to identify conditions influencing CCMM's implementation and to explore necessary and sufficient combinations of conditions (i.e., solutions) for improving patients' glycated hemoglobin (HbA1c) control (outcome).ResultsKey conditions included implementation process, couple's role in diabetes management, their belief and perception of CCMM, as well as objective obstacles and subjective initiative for behavior change. Accordingly, major barriers in CCMM's implementation were patients' strong autonomy (particularly among husbands), misbelief and misperception about diabetes management as a result of low literacy, and mistrust of the practitioners. QCA further revealed that no single condition was necessary for effective HbA1c control, while three types of their combinations would be sufficient. Solution 1 and 2 both comprised the presence of spousal willingness to help, plus correct belief and perception of diabetes management, well embodying the utility of couple collaborative management in supporting patients' HbA1c control. On the other hand, solution 3 indicated that high-quality implementation even without spousal support, can promote the patient's subjective initiative to overcome objective obstacles, suggesting enhanced self-management for HbA1c control.ConclusionsTailored CCMM should be implemented in reference to older couple's preferences and literacy levels, to ensure intervention fidelity, and establish correct understanding of collaborative management among them.

Project description:BACKGROUND:Physical frailty, characterized by reduced physiologic complexity and ability to cope with stressors, is closely associated with cognitive impairment, which increases the risk of poor clinical outcomes. To better capture the association between frailty and cognitive impairment, a new construct, cognitive frailty, has been proposed. Cognitive frailty is a clinical condition characterized by the simultaneous presence of physical frailty and cognitive impairment. There is little evidence on the relationship between physical frailty and cognition, as well as cognitive frailty, in Chinese older adults. We aimed to elucidate whether physical frailty is associated with cognitive impairment in an older Chinese population. METHODS:Data were obtained from the China Comprehensive Geriatric Assessment Study. The sample comprised 3202 community-dwelling adults, aged 60 years and older, from seven Chinese cities. Physical frailty was assessed using a modified, four-item version of the Fried criteria, according to frailty phenotype. Cognitive function was assessed using the Mini-Mental State Examination (MMSE). RESULTS:The prevalence of physical frailty, prefrailty, cognitive impairment, and cognitive frailty was 9.9, 33.9, 7.5, and 2.3%, respectively (weighted: 8.8, 33.8, 6.5, and 2.0%). The prevalence of the combination of prefrail/frail and cognitive impairment was 5.1% (weighted 4.5%). Frail participants performed worse on global cognition and all cognitive domains than robust and prefrail participants. The MMSE total score was positively correlated with walking speed and negatively correlated with age and frailty. A multivariate logistic regression revealed that after adjusting for age, gender, education level, living area, and chronic diseases, frailty, exhaustion, slowness, and inactivity were significantly associated with poor global cognition. CONCLUSIONS:The standard prevalence of physical frailty, prefrailty, cognitive impairment, and cognitive frailty in community-dwelling older adults in China was 8.8, 33.8, 6.5, and 2.0%, respectively. Frailty, exhaustion, slowness, and inactivity were significantly associated with poor global cognition.

Project description:BackgroundAlthough China has a large number of older people living with diabetes and hypertension, the primary care system is underdeveloped and so management of these conditions in community care settings is suboptimal. Studies have shown that the collaborative care model across care settings that address both pharmacology and nonpharmacology interventions can achieve hypertension control for older people with diabetes. Barriers to implementing and evaluating this model of care are widely recognized in low and middle-income countries including China. This study will therefore test the hypothesis that a hypertension management program built on collaboration between hospitals and community health service centers in China can improve blood pressure control in people aged 60 years and older with diabetes as compared to usual care.MethodsA cluster randomized controlled trial will randomly allocate 10 wards from four hospitals in Nanchang to either an intervention group (N = 5) or a usual care group (N = 5). At least 27 participants will be recruited from each ward and the estimated sample size will be 135 patients in each group. The intervention includes individualized self-care education prior to discharge and 6-month follow-up in community health service centers. Health professionals from both hospitals and community health service centers will be resourced to collaborate on the implementation of the postdischarge interventions that reinforce self-care. The primary outcome is systolic blood pressure at 6-month follow-up adjusted for baseline value. Secondary outcomes are self-care knowledge, treatment adherence, HbA1c and lipid levels, quality of life, the incidence of adverse events and the incidence of unplanned hospital readmission at 6-month follow-up adjusted for baseline value. A multilevel mixed-effect linear regression model will be used to compare the changes in health outcomes between the intervention and usual care groups.DiscussionThis study will determine whether collaborative care among health professionals between hospitals and community health service centers will improve hypertension management for older people with diabetes in the study sites. The program, if effective, will have an immediate application to hypertension management in the healthcare system in China.Trial registrationAustralia New Zealand Clinical Trials Registry, ACTRN12617001352392 . Retrospectively registered on 26 September 2017.

Project description:BackgroundA growing body of literature supports the efficacy of the health-social approach for the implementation of complex interventions to enhance self-care health management among community-dwelling older adults. However, there is little research on how interventions with this approach are implemented and disseminated in a real community setting.MethodsThis pilot study adopted an effectiveness-implementation hybrid design to 1) evaluate the effectiveness of a community-based Health-Social Partnership Program (HSPP) and 2) explore the reach, adoption, implementation, and maintenance of the HSPP in the community. Potential participants were recruited if they were aged 60 or above, owned a smartphone, and were cognitively competent. The participants received nurse-led case management with support from a social service team. Factors that hindered or facilitated the program delivery were examined to determine the implementation outcomes and sustained effects of the program. Data were collected at pre-intervention (T1), immediately post-intervention (T2), and 3 months post-intervention (T3).ResultsNinety-two older adults joined and completed the program. The recruitment rate was 76.7%. A significant interaction effect was found for the mean self-efficacy scores from T1 to T2 (Wald χ2 = 12.28, p ≤ .001). Barriers to widespread program implementation included manpower shortage, lack of experienced staff, and unpredictable environment, whereas facilitators, as suggested by the older adults, providers, and community staff members, included regular communication between the research and service teams, recruitment of participants through community centers with the support of the research team, and seamless partnership among the health-social partnership team members. Strong implementation fidelity was achieved with zero attrition rate.ConclusionMost conventional randomized controlled trials investigating the effects of community-based programs have tended to control the contextual factors rather than incorporate the program in a real setting. This pilot study was the first to use a hybrid model to test the effectiveness and outcomes of HSPP implementation. The results imply that the program has a high potential sustainability in the real-life context.Trial registrationThis study was registered at clinicaltrials.gov (NCT04442867; date of first registration 23/06/2020).

Project description:BackgroundSeveral studies have demonstrated that older adults with type 2 diabetes mellitus (T2DM) have a higher risk of falls compared to those without T2DM, which may lead to disability and a lower quality of life. While, limited prospective studies have quantified the associations in southern China. We conducted a longitudinal cohort study to quantify the associations between T2DM and falls and investigate the risk factors of falls among community-dwelling elderly people in Guangzhou, China.MethodsThe population-based study included 8800 residents aged 65 and over in 11 counties of Guangzhou at baseline in 2020 and then prospectively followed up through 2022. Of 6169 participants had complete follow-up and were included in the present study. A fall event was identified by self-reported. The Cox regression was applied to quantify the associations between T2DM and falls, and hazard ratios (HRs) were calculated to the factors associated with falls among participants.ResultsThe median follow-up time for participants was 2.42 years. During the follow-up period, the incidence of falls among all participants was 21.96%. After adjusting for covariates in Cox regression models, T2DM remained a significant risk factor for falls, with HR of 1.781 (95% CI: 1.600-1.983) in the unadjusted covariates model and 1.757 (1.577-1.957) in the adjusted covariates model. Female (1.286, 1.136-1.457), older age (≥ 80: 1.448, 1.214-1.729), single marital status (1.239, 1.039-1.477), lower education level (primary school and below: 1.619, 1.004-1.361), hypertension (1.149, 1.026-1.286) and stroke (1.619, 1.176-2.228) were associated with a higher risk of falls, whereas everyday physical exercise (0.793, 0.686-0.918) was associated with a lower risk of falls.ConclusionFalls are common, with risks between T2DM and falls quantified and several factors investigated in the longitudinal cohort study among community-dwelling elderly people in Guangzhou, China. Targeted action on the risk factors may reduce the burden of falls in elderly people with T2DM in the future.

Project description:BackgroundAlthough exercise seems to be beneficial for type 2 diabetes mellitus (T2DM) patients, there is limited research elucidating the optimal accessible indices of adiposity and insulin resistance for identifying elderly T2DM patients with poor glycemic control, which could be improved by performing regular exercise.MethodsA community-based, cross-sectional study was conducted with 918 Chinese elderly individuals with T2DM in Zhejiang. Relevant risk factors for poor glycemic control, as determined using glycated haemoglobin A1c (HbA1c) > 7%, were explored using logistic regression analyses and included body mass index (BMI), waist circumference (WC), waist to height ratio (WHtR), fasting blood glucose (FBG), triglycerides (TGs), total cholesterol (TC), the product of fasting triglycerides and glucose (TyG), visceral adiposity index (VAI), lipid accumulation product (LAP), TyG-BMI, and TyG-WC. Comparisons of the risk factors' ability to discriminate poor glycemic control as well as their optimal cutoff values were determined using receiver operating characteristic (ROC) analyses, and then the extent of poor glycemic control risk reduction through regular exercise was examined using multivariate logistic regression analyses.ResultsThe overall poor glycemic control rate was 49.3%. The factors associated with poor glycemic control included FBG > 3.869, TyG > 8.73, TyG-BMI > 222.45, and TyG-WC > 713.48 in logistic regression analyses. The optimal cutoff points of FBG, TyG, TyG-WC, and TyG-BMI in discriminating poor glycemic control were 7.38, 9.22, 813.33, and 227.77, and their corresponding areas under the ROC curves were 0.864(0.840-0.886), 0.684(0.653-0.714), 0.604(0.571-0.635), and 0.574(0.541-0.606), respectively. Occasional and regular exercise reduced the odds ratios (95% confidence interval) of poor glycemic control to 0.187 (0.063-0.557) and 0.183 (0.059-0.571) for subjects with TyG-WC > 813.33 (p = 0.008), to 0.349 (0.156-0.782) and 0.284 (0.123-0.652) for subjects with TyG > 9.22 (p = 0.011), and to 0.390 (0.175-0.869) and 0.300(0.130-0.688) for subjects with TyG-BMI > 227.77 (p = 0.017), respectively, after adjusting for multiple confounding factors.ConclusionAmong elderly individuals with T2DM, poor glycemic control risk might be identified using indices calculated from FBG, TG, BMI, and WC measurements, which are indicative of adiposity and insulin resistance. TyG-WC seems to be an accessible and useful indicator to identify which elderly T2DM patients would benefit from performing regular exercise to achieve good glycemic control.

Dataset Information

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.

Background

Methods

Discussion

Trial registration

Publications

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.

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