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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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          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.

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          Most cited references 21

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          Self-efficacy: toward a unifying theory of behavioral change.

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            Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin.

            Type 2 diabetes affects approximately 8 percent of adults in the United States. Some risk factors--elevated plasma glucose concentrations in the fasting state and after an oral glucose load, overweight, and a sedentary lifestyle--are potentially reversible. We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes. We randomly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo, metformin (850 mg twice daily), or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week. The mean age of the participants was 51 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 34.0; 68 percent were women, and 45 percent were members of minority groups. The average follow-up was 2.8 years. The incidence of diabetes was 11.0, 7.8, and 4.8 cases per 100 person-years in the placebo, metformin, and lifestyle groups, respectively. The lifestyle intervention reduced the incidence by 58 percent (95 percent confidence interval, 48 to 66 percent) and metformin by 31 percent (95 percent confidence interval, 17 to 43 percent), as compared with placebo; the lifestyle intervention was significantly more effective than metformin. To prevent one case of diabetes during a period of three years, 6.9 persons would have to participate in the lifestyle-intervention program, and 13.9 would have to receive metformin. Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk. The lifestyle intervention was more effective than metformin.
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              Developing and evaluating complex interventions: the new Medical Research Council guidance

              Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
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                Author and article information

                Contributors
                miklavcic@chapman.edu
                kdfraser@ualberta.ca
                ploegj@mcmaster.ca
                mreid@mcmaster.ca
                fisheka@mcmaster.ca
                gafni@mcmaster.ca
                griffith@mcmaster.ca
                shirst@ucalgary.ca
                cherylas@ualberta.ca
                thabanl@mcmaster.ca
                jean.triscott@ualberta.ca
                ross.upshur@utoronto.ca
                Journal
                BMC Geriatr
                BMC Geriatr
                BMC Geriatrics
                BioMed Central (London )
                1471-2318
                13 May 2020
                13 May 2020
                2020
                : 20
                Affiliations
                [1 ]GRID grid.254024.5, ISNI 0000 0000 9006 1798, Schmid College of Science and Technology, , Chapman University, ; Orange, California 92866 USA
                [2 ]GRID grid.254024.5, ISNI 0000 0000 9006 1798, School of Pharmacy, , Chapman University, ; Irvine, California 92618 USA
                [3 ]GRID grid.17089.37, Faculty of Nursing, , University of Alberta, ; Edmonton, Alberta T6G2R3 Canada
                [4 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, School of Nursing, and Scientific Director, Aging, Community and Health Research Unit, , School of Nursing McMaster University, ; 1280 Main Street West, Hamilton, ON L8S 4K1 Canada
                [5 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, Aging, Community and Health Research Unit, , School of Nursing, McMaster University, ; Hamilton, Canada
                [6 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, McMaster Institute for Research on Aging/Collaborative for Health and Aging (OSSU SPOR Research Centre), Associate Member, Health, Evidence and Impact, , McMaster University, ; 1280 Main Street West, Hamilton, ON L8S 4K1, HSC 3N25B Canada
                [7 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, Aging, Community and Health Research Unit, School of Nursing, , McMaster University, ; 1280 Main Street West, Hamilton, ON L8S 4K1 Canada
                [8 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, Department of Health Research Methods, Evidence, and Impact; and Centre for Health Economics and Policy Analysis, , McMaster University, ; Hamilton, Ontario L8S 4K1 Canada
                [9 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, Department of Health Research Methods, Evidence, and Impact, , McMaster University, ; 1280 Main Street West, Hamilton, ON L8S 4K1 Canada
                [10 ]GRID grid.22072.35, ISNI 0000 0004 1936 7697, Faculty of Nursing, , University of Calgary, ; Calgary, Alberta T2N 1N4 Canada
                [11 ]GRID grid.17089.37, Faculty of Pharmacy and Pharmaceutical Sciences, , University of Alberta, ; 3-171 Edmonton Clinic Health Academy, Edmonton, Alberta T6G 1C9 Canada
                [12 ]GRID grid.25073.33, ISNI 0000 0004 1936 8227, Department of Health Research Methods, Evidence, and Impact, , McMaster University, ; Hamilton, Ontario L8S 4K1 Canada
                [13 ]GRID grid.413136.2, ISNI 0000 0000 8590 2409, Care of the Elderly Division, , Glenrose Rehabilitation Hospital, ; Rm 1244 10230-111 Avenue, Edmonton, Alberta T5G 0B7 Canada
                [14 ]GRID grid.17089.37, Department of Family Medicine, Faculty of Medicine & Dentistry, , University of Alberta, ; Edmonton, Canada
                [15 ]GRID grid.17063.33, ISNI 0000 0001 2157 2938, Division of Clinical Public Health, Dalla Lana School of Public Health, , University of Toronto, ; Room 678 155 College Street, Toronto, Ontario M5T 3M7 Canada
                Article
                1557
                10.1186/s12877-020-01557-0
                7218835
                32404059
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                Funding
                Funded by: Canadian Institutes of Health Research Signature Initiative in Community-Based Primary Healthcare
                Award ID: TTF 128261
                Award Recipient :
                Funded by: Ontario Ministry of Health and Long-Term Care Health System Research Fund Program
                Award ID: 06669
                Award Recipient :
                Funded by: Canadian Institute of Health Research Tier 2 Canada Research Chair
                Award ID: 950-231515
                Award Recipient :
                Categories
                Research Article
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                © The Author(s) 2020

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