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Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial.

ABSTRACT: BACKGROUND:Type II diabetes mellitus (T2DM) affects upwards of 25% of Canadian older adults and is associated with high comorbidity and burden. Studies show that lifestyle factors and self-management are associated with improved health outcomes, but many studies lack rigour or exclude older adults, particularly those with multimorbidity. More evidence is needed on the effectiveness of community-based self-management programs in older adults with T2DM and multimorbidity. The study purpose is to evaluate the effect of a community-based intervention versus usual care on physical functioning, mental health, depressive symptoms, anxiety, self-efficacy, self-management, and healthcare costs in older adults with T2DM and 2 or more comorbidities. METHODS:Community-living older adults with T2DM and two or more chronic conditions were recruited from three Primary Care Networks (PCNs) in Alberta, Canada. Participants were randomly allocated to the intervention or control group in this pragmatic randomized controlled trial comparing the intervention to usual care. The intervention involved up to three in-home visits, a monthly group wellness program, monthly case conferencing, and care coordination. The primary outcome was physical functioning. Secondary outcomes included mental functioning, anxiety, depressive symptoms, self-efficacy, self-management, and the cost of healthcare service use. Intention-to-treat analysis was performed using ANCOVA modeling. RESULTS:Of 132 enrolled participants (70-Intervention, 62-Control), 42% were 75?years or older, 55% were female, and over 75% had at least six chronic conditions (in addition to T2DM). No significant group differences were seen for the baseline to six-month change in physical functioning (mean difference: -0.74; 95% CI: -?3.22, 1.74; p-value: 0.56), mental functioning (mean difference: 1.24; 95% CI: -?1.12, 3.60; p-value: 0.30), or other secondary outcomes.. CONCLUSION:No significant group differences were seen for the primary outcome, physical functioning (PCS). Program implementation, baseline differences between study arms and chronic disease management services that are part of usual care may have contributed to the modest study results. Fruitful areas for future research include capturing clinical outcome measures and exploring the impact of varying the type and intensity of key intervention components such as exercise and diet. TRIAL REGISTRATION:NCT02158741 Date of registration: June 9, 2014.

SUBMITTER: Miklavcic JJ

PROVIDER: S-EPMC7218835 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial.

Miklavcic John J JJ Fraser Kimberly D KD Ploeg Jenny J Markle-Reid Maureen M Fisher Kathryn K Gafni Amiram A Griffith Lauren E LE Hirst Sandra S Sadowski Cheryl A CA Thabane Lehana L Triscott Jean A C JAC Upshur Ross R

BMC geriatrics 20200513 1

<h4>Background</h4>Type II diabetes mellitus (T2DM) affects upwards of 25% of Canadian older adults and is associated with high comorbidity and burden. Studies show that lifestyle factors and self-management are associated with improved health outcomes, but many studies lack rigour or exclude older adults, particularly those with multimorbidity. More evidence is needed on the effectiveness of community-based self-management programs in older adults with T2DM and multimorbidity. The study purpose ...[more]

PMID: 32404059

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Project description:BackgroundMultimorbidity, the co-existence of 2+ (or 3+) chronic diseases in an individual, is an increasingly common global phenomenon leading to reduced quality of life and functional status, and higher healthcare service use and mortality. There is an urgent need to develop and test new models of care that incorporate the components of multimorbidity interventions recommended by international organizations, including care coordination, interdisciplinary teams, and care plans developed with patients that are tailored to their needs and preferences.PurposeTo determine the effectiveness of a 6-month, community-based, multimorbidity intervention compared to usual home care services for community-dwelling older adults (age 65+ years) with multimorbidity (3+ chronic conditions) that were newly referred to and receiving home care services.MethodsA pragmatic, parallel, two-arm randomized controlled trial evaluated the intervention, which included in-home visits by an interdisciplinary team, personal support worker visits, and monthly case conferences. The study took place in two sites in central Ontario, Canada. Eligible and consenting participants were randomly allocated to the intervention and control group using a 1:1 ratio. The participants, statistician/analyst, and research assistants collecting assessment data were blinded. The primary outcome was the Physical Component Summary (PCS) score of the 12-Item Short-Form health survey (SF-12). Secondary outcomes included the SF-12 Mental Component Summary (MCS) score, Center for Epidemiological Studies of Depression (CESD-10), Generalized Anxiety Disorder (GAD-7), Self-Efficacy for Managing Chronic Disease, and service use and costs. Analysis of covariance (ANCOVA) tested group differences using multiple imputation to address missing data, and non-parametric methods explored service use and cost differences.Results59 older adults were randomized into the intervention (n = 30) and control (n = 29) groups. At baseline, groups were similar for the primary outcome and number of chronic conditions (mean of 8.6), but the intervention group had lower mental health status. The intervention was cost neutral and no significant group differences were observed for the primary outcome of PCS from SF-12 (mean difference: -4.94; 95% CI: -12.53 to 2.66; p = 0.20) or secondary outcomes.ConclusionWe evaluated a 6-month, self-management intervention for older adults with multimorbidity. While the intervention was cost neutral in comparison to usual care, it was not found to improve the PCS from SF-12 or secondary health outcomes. Recruitment and retention challenges were significant obstacles limiting our ability to assess intervention effectiveness. Yet, the intervention was grounded in internationally-endorsed recommendations and implemented in a practice setting (home care) viewed as a key upstream resource fostering independence in older adults. These features collectively support the identification of ways to recruit/retain older adults and test alternative implementation strategies for interventions that are based on sound principles of multimorbidity management.

Project description:ObjectiveTo evaluate the effectiveness of a nurse-led hospital-to-home transitional care intervention versus usual care on mental functioning (primary outcome), physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health service use costs in older adults with multimorbidity (≥ 2 comorbidities) and depressive symptoms.Design and settingPragmatic multi-site randomized controlled trial conducted in three communities in Ontario, Canada. Participants were allocated into two groups of intervention and usual care (control).Participants127 older adults (≥ 65 years) discharged from hospital to the community with multimorbidity and depressive symptoms.InterventionThis evidence-based, patient-centred intervention consisted of individually tailored care delivery by a Registered Nurse comprising in-home visits, telephone follow-up and system navigation support over 6-months.Outcome measuresThe primary outcome was the change in mental functioning, from baseline to 6-months. Secondary outcomes were the change in physical functioning, depressive symptoms, anxiety, perceived social support, patient experience, and health service use cost, from baseline to 6-months. Intention-to-treat analysis was performed using ANCOVA modeling.ResultsOf 127 enrolled participants (63-intervention, 64-control), 85% had six or more chronic conditions. 28 participants were lost to follow-up, leaving 99 (47 -intervention, 52-control) participants for the complete case analysis. No significant group differences were seen for the baseline to six-month change in mental functioning or other secondary outcomes. Older adults in the intervention group reported receiving more information about health and social services (p = 0.03) compared with the usual care group.ConclusionsAlthough no significant group differences were seen for the primary or secondary outcomes, the intervention resulted in improvements in one aspect of patient experience (information about health and social services). The study sample fell below the target sample (enrolled 127, targeted 216), which can account for the non-significant findings. Further research on the impact of the intervention and factors that contribute to the results is recommended.Trial registrationclinicaltrials.gov Identifier: NCT03157999.

Project description:BackgroundOlder adults (≥65 years) with diabetes and multiple chronic conditions (MCC) (> 2 chronic conditions) experience reduced function and quality of life, increased health service use, and high mortality. Many community-based self-management interventions have been developed for this group, however the evidence for their effectiveness is limited. This paper presents the protocol for a randomized controlled trial (RCT) comparing the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) to usual care in older adults with diabetes and MCC and their caregivers.MethodsWe will conduct a cross-jurisdictional, multi-site implementation-effectiveness type II hybrid RCT. Eligibility criteria are: ≥65 years, diabetes diagnosis (Type 1 or 2) and at least one other chronic condition, and enrolled in a primary care or diabetes education program. Participants will be randomly assigned to the intervention (ACHRU-CPP) or control arm (1:1 ratio). The intervention arm consists of home/telephone visits, monthly group wellness sessions, multidisciplinary case conferences, and system navigation support. It will be delivered by registered nurses and registered dietitians/nutritionists from participating primary care or diabetes education programs and program coordinators from community-based organizations. The control arm consists of usual care provided by the primary care setting or diabetes education program. The primary outcome is the change from baseline to 6 months in mental functioning. Secondary outcomes will include, for example, the change from baseline to 6 months in physical functioning, diabetes self-management, depressive symptoms, and cost of use of healthcare services. Analysis of covariance (ANCOVA) models will be used to analyze all outcomes, with intention-to-treat analysis using multiple imputation to address missing data. Descriptive and qualitative data from older adults, caregivers and intervention teams will be used to examine intervention implementation, site-specific adaptations, and scalability potential.DiscussionAn interprofessional intervention supporting self-management may be effective in improving health outcomes and client/caregiver experience and reducing service use and costs in this complex population. This pragmatic trial includes a scalability assessment which considers a range of effectiveness and implementation criteria to inform the future scale-up of the ACHRU-CPP.Trial registrationClinical Trials.gov Identifier NCT03664583 . Registration date: September 10, 2018.

Project description:Background:Aging is associated with reduced muscle mass and strength leading to impaired physical function. Resistance training programs incorporated into older adults' real-life settings may have the potential to counteract these changes. We evaluated the effectiveness of 8 months resistance training using easily available, low cost equipment compared to physical activity counselling on physical function, muscle strength, and body composition in community-dwelling older adults receiving home care. Methods:This open label, two-armed, parallel group, cluster randomized trial recruited older adults above 70?years (median age 86.0 (Interquartile range 80-90) years) receiving home care. Participants were randomized at cluster level to the resistance training group (RTG) or the control group (CG). The RTG trained twice a week while the CG were informed about the national recommendations for physical activity and received a motivational talk every 6th week. Outcomes were assessed at participant level at baseline, after four, and 8 months and included tests of physical function (chair rise, 8?ft-up-and-go, preferred- and maximal gait speed, and stair climb), maximal strength, rate of force development, and body composition. Results:Twelve clusters were allocated to RTG (7 clusters, 60 participants) or CG (5 clusters, 44 participants). The number of participants analyzed was 56-64 (6-7 clusters) in RTG and 20-42 (5 clusters) in CG. After 8 months, multilevel linear mixed models showed that RTG improved in all tests of physical function and maximal leg strength (9-24%, p?=?0.01-0.03) compared to CG. No effects were seen for rate of force development or body composition. Conclusion:This study show that resistance training using easily available, low cost equipment is more effective than physical activity counselling for improving physical function and maximal strength in community-dwelling older adults receiving home care. Trial registration:ISRCTN1067873.

Project description:ImportanceTiming and coordination exercises may be an important addition to community-based health promotion exercise programs to improve walking in older adults.ObjectiveTo compare the effectiveness of the On the Move group exercise program, which focuses on the timing and coordination of movement, with a seated strength, endurance, and flexibility program (usual care) at improving function, disability, and walking ability of older adults.Design, setting, and participantsCluster-randomized, single-blind intervention trial. Thirty-two independent living facilities, senior apartment buildings, and senior community centers were randomized to On the Move (16 sites; 152 participants) or usual care (16 sites; 146 participants). Participants were 65 years or older, able to ambulate independently with a gait speed of at least 0.60 m/s, able to follow 2-step commands, and were medically stable.InterventionsExercise classes were 50 minutes, twice a week for 12 weeks and had 10 or fewer participants per class. On the Move consisted of warm-up, timing and coordination (stepping and walking patterns), strengthening, and stretching exercises. The usual-care program consisted of warm-up, strength, endurance, and stretching exercises.Main outcomes and measuresThe primary outcomes were self-report of function and disability (Late Life Function and Disability Instrument) and mobility (6-minute walk distance and gait speed) assessed by blinded individuals.ResultsParticipants (mean [SD] age, 80.0 [8.1] years) were mostly female (251 [84.2%]) and white (249 [83.6%]) and had a mean (SD) of 2.8 (1.4) chronic conditions. Intervention groups were similar on baseline characteristics. Postintervention, 142 (93.4%) participants in On the Move and 139 (95.2%) participants in usual care completed testing. On the Move had greater mean (SD) improvements than the usual-care group in gait speed (0.05 [0.13] vs -0.01 [0.11] m/s; adjusted difference = 0.05 [0.02] m/s; P = .002) and 6-minute walk distance (20.6 [57.1] vs 4.1 [55.6] m; adjusted difference = 16.7 [7.4] m; P = .03). Attendance was greater in the usual-care program compared with On the Move (95 [65.1%] vs 76 [50.0%] attended ≥20 classes; P = .03). There were no significant differences in any of the other primary or secondary outcomes.Conclusions and relevanceThe On the Move group exercise program was more effective at improving mobility than a usual-care exercise program, despite lower attendance. Additional research examining the impact of the intervention on long-term disability outcomes is needed before recommending routine implementation into clinical practice.Trial registrationclinicaltrials.gov Identifier: NCT01986647.

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Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial.

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Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial.

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