Effectiveness of the Aging, Community and Health Research Unit’s Community Partnership Program (ACHRU-CPP) for Older Adults with Diabetes and Multiple Chronic Conditions: A Multi-Site, Pragmatic Randomized Controlled Trial
Background: Modifiable risk factors for type 2 diabetes are primarily lifestyle related. However, we know little about the impact of low-intensity community-based lifestyle interventions on health and health services use. In this patient-oriented research, we sought to assess the effectiveness on quality of life of a 6-month, person-centred community-based lifestyle intervention (additional to usual care) for community-dwelling older adults (≥ 65 years) with diabetes and at least one other chronic condition, and their caregivers compared to usual care. Methods: We conducted a type II hybrid effectiveness-implementation randomized controlled trial (RCT) at two sites in each of three Canadian provinces. Knowledge user partners were engaged throughout. Participants were eligible if aged 65+ years, diagnosed with diabetes and multimorbidity, enrolled in a primary care setting or diabetes education program, capable of providing consent, and spoke English or French. Enrolled participants were randomly assigned to intervention and control arms (1:1). The intervention arm consisted of usual care plus: 1) up to 3 home/telephone visits; 2) up to 6 monthly group education sessions; 3) ongoing nurse-led care coordination and system navigation; 4) caregiver engagement/support; 5) monthly interdisciplinary team case conferences; and 6) collaboration with primary care, as needed. The control arm received usual care. The primary outcome was quality of life (measure: SF-12 Mental Component Summary [MCS]); intention-to-treat was used with missing data multiply imputed. Secondary outcomes and sensitivity analyses were tested. Results: The trial ran from July 2019 - May 2022; sites started at different points within this period. Of 619 eligible participants, 295 (48%) were enrolled and 246 (83%) completed 6-month data collection. Our primary analysis showed no difference between groups in the SF12-MCS (mean difference: ?0.71, 95% CI ?2.66 to 1.24, p = 0.47) or secondary outcomes (e.g., anxiety, self-care, physical activity); sensitivity analyses showed consistent results. Discussion: A low intensity 6-month community-based lifestyle intervention for community-dwelling older adults (≥65 years) with diabetes and at least one other chronic condition did not improve quality of life or other outcomes, in contrast to our previous studies. The trial ran during COVID-19, with disruptions and the shift to virtual delivery potentially diluting intervention effects.
References
[1]
Sinnige, J., Braspenning, J., Schellevis, F., Stirbu-Wagner, I., Westert, G. and Korevaar, J. (2013) The Prevalence of Disease Clusters in Older Adults with Multiple Chronic Diseases—A Systematic Literature Review. PLOSONE, 8, e79641. https://doi.org/10.1371/journal.pone.0079641
[2]
Menke, A., Casagrande, S., Geiss, L. and Cowie, C.C. (2015) Prevalence of and Trends in Diabetes among Adults in the United States, 1988-2012. JAMA, 314, 1021-1029. https://doi.org/10.1001/jama.2015.10029
[3]
Grembowski, D., Schaefer, J., Johnson, K.E., Fischer, H., Moore, S.L., Tai-Seale, M., et al. (2014) A Conceptual Model of the Role of Complexity in the Care of Patients with Multiple Chronic Conditions. MedicalCare, 52, S7-S14. https://doi.org/10.1097/mlr.0000000000000045
[4]
Stannard, S., Berrington, A., Paranjothy, S., Owen, R., Fraser, S., Hoyle, R., et al. (2023) A Conceptual Framework for Characterising Lifecourse Determinants of Multiple Long-Term Condition Multimorbidity. JournalofMultimorbidityandComorbidity, 13, 1-13.
[5]
Gregg, E.W. and Wing, R. (2016) Looking again at the Look AHEAD Study. Lancet Diabetes Endocrinol, 5, 763-764.
[6]
Wing, R.R., Look AHEAD Research Group (2021) Does Lifestyle Intervention Improve Health of Adults with Overweight/obesity and Type 2 Diabetes? Findings from the Look AHEAD Randomized Trial. Obesity, 29, 1246-1258. https://doi.org/10.1002/oby.23158
[7]
Delahanty, L.M., Dalton, K.M., Porneala, B., Chang, Y., Goldman, V.M., Levy, D., et al. (2015) Improving Diabetes Outcomes through Lifestyle Change—A Randomized Controlled Trial. Obesity, 23, 1792-1799. https://doi.org/10.1002/oby.21172
[8]
Houston, D.K., Leng, X., Bray, G.A., Hergenroeder, A.L., Hill, J.O., Jakicic, J.M., et al. (2014) A Long‐Term Intensive Lifestyle Intervention and Physical Function: The Look ahead Movement and Memory Study. Obesity, 23, 77-84. https://doi.org/10.1002/oby.20944
[9]
Look AHEAD Research Group (2014) Eight‐Year Weight Losses with an Intensive Lifestyle Intervention: The Look AHEAD Study. Obesity, 22, 5-13. https://doi.org/10.1002/oby.20662
[10]
Bandura, A. (1989) Human Agency in Social Cognitive Theory. American Psychologist, 44, 1175-1184. https://doi.org/10.1037/0003-066x.44.9.1175
[11]
Bandura, A. (2004) Health Promotion by Social Cognitive Means. Health Education & Behavior, 31, 143-164. https://doi.org/10.1177/1090198104263660
[12]
Heiss, V.J. and Petosa, R.L. (2016) Social Cognitive Theory Correlates of Moderate-Intensity Exercise among Adults with Type 2 Diabetes. Psychology, Health & Medicine, 21, 92-101. https://doi.org/10.1080/13548506.2015.1017510
[13]
Tan, C.C.L., Cheng, K.K.F. and Wang, W. (2015) Self‐Care Management Programme for Older Adults with Diabetes: An Integrative Literature Review. International Journal of Nursing Practice, 21, 115-124. https://doi.org/10.1111/ijn.12388
[14]
Befort, C.A., VanWormer, J.J., Desouza, C., Ellerbeck, E.F., Gajewski, B., Kimminau, K.S., et al. (2021) Effect of Behavioral Therapy with In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss among Patients with Obesity in Rural Clinical Practice. JAMA, 325, 363-372. https://doi.org/10.1001/jama.2020.25855
[15]
Liss, D.T., Finch, E.A., Cooper, A., Sheth, A., Tejuosho, A.D., Lancki, N., et al. (2018) One-Year Effects of a Group-Based Lifestyle Intervention in Adults with Type 2 Diabetes: A Randomized Encouragement Trial. Diabetes Research and Clinical Practice, 140, 36-44. https://doi.org/10.1016/j.diabres.2018.03.030
[16]
Williams, G.C., Niemiec, C.P., Elliot, A.J., LaGuardia, J.G., Gorin, A.A. and Rigby, C.S. (2014) Virtual Look AHEAD Program: Initial Support for a Partly Virtualized Intensive Lifestyle Intervention in Type 2 Diabetes. Diabetes Care, 37, e169-e170. https://doi.org/10.2337/dc14-0831
[17]
Krukowski, R.A., Hare, M.E., Talcott, G.W., Johnson, K.C., Richey, P.A., Kocak, M., et al. (2014) Dissemination of the Look AHEAD Intensive Lifestyle Intervention in the United States Air Force: Study Rationale, Design and Methods. Contemporary Clinical Trials, 40, 232-239. https://doi.org/10.1016/j.cct.2014.12.014
[18]
Song, Y., Beltran Puerta, J., Medina-Aedo, M., Canelo-Aybar, C., Valli, C., Ballester, M., et al. (2023) Self-Management Interventions for Adults Living with Type II Diabetes to Improve Patient-Important Outcomes: An Evidence Map. Healthcare, 11, 3156. https://doi.org/10.3390/healthcare11243156
[19]
Cruz‐Jentoft, A.J., Carpena‐Ruiz, M., Montero‐Errasquín, B., Sánchez‐Castellano, C. and Sánchez‐García, E. (2013) Exclusion of Older Adults from Ongoing Clinical Trials about Type 2 Diabetes Mellitus. Journal of the American Geriatrics Society, 61, 734-738. https://doi.org/10.1111/jgs.12215
[20]
Ploeg, J., Markle-Reid, M., Valaitis, R., Fisher, K., Ganann, R., Blais, J., et al. (2022) The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP) for Older Adults with Diabetes and Multiple Chronic Conditions: Study Protocol for a Randomized Controlled Trial. BMC Geriatrics, 22, Article No. 99. https://doi.org/10.1186/s12877-021-02651-7
[21]
Bandura, A. (1977) Self-Efficacy: Toward a Unifying Theory of Behavioral Change. Psychological Review, 84, 191-215.
[22]
Markle-Reid, M., Ploeg, J., Fisher, K., Reimer, H., Kaasalainen, S., Gafni, A., et al. (2016) The Aging, Community and Health Research Unit—Community Partnership Program for Older Adults with Type 2 Diabetes and Multiple Chronic Conditions: A Feasibility Study. Pilot and Feasibility Studies, 2, Article No. 22. https://doi.org/10.1186/s40814-016-0063-1
[23]
Markle‐Reid, M., Ploeg, J., Fraser, K.D., Fisher, K.A., Bartholomew, A., Griffith, L.E., et al. (2018) Community Program Improves Quality of Life and Self‐Management in Older Adults with Diabetes Mellitus and Comorbidity. Journal of the American Geriatrics Society, 66, 263-273. https://doi.org/10.1111/jgs.15173
[24]
Fisher, K., Carusone, S.C., Ganann, R., Markle-Reid, M., Northwood, M. and Sherifali, D. (2025) Transforming Healthcare by Prioritizing Qualitative and Quantitative Clinical Trial Evidence: Evaluating the Aging, Community and Health Research Unit’s Community Partnership Program for Older Adults (ACHRU-CPP). Trials, 26, Article No. 154. https://doi.org/10.1186/s13063-025-08839-1
[25]
Northwood, M., Markle-Reid, M., Ganann, R. and Fisher, K. (2023) Assessing the Scalability of a Community-Based Self-Management Intervention for Older Adults with Diabetes and Other Chronic Conditions—The Aging, Community and Health Research Unit Community Partnership Program (ACHRU-CPP). International Journal of Integrated Care, 23, Article 615. https://doi.org/10.5334/ijic.icic23237
[26]
Schulz, K.F., Altman, D.G. and Moher, D. (2010) CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. BMJ, 340, c332-c332. https://doi.org/10.1136/bmj.c332
[27]
Curran, G.M., Bauer, M., Mittman, B., Pyne, J.M. and Stetler, C. (2012) Effectiveness-Implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact. Medical Care, 50, 217-226. https://doi.org/10.1097/mlr.0b013e3182408812
[28]
Curran, G.M., Landes, S.J., McBain, S.A., Pyne, J.M., Smith, J.D., Fernandez, M.E., et al. (2022) Reflections on 10 Years of Effectiveness-Implementation Hybrid Studies. Frontiers in Health Services, 2, Article ID: 1053496. https://doi.org/10.3389/frhs.2022.1053496
[29]
Hahn, O.M. and Schilsky, R.L. (2012) Randomized Controlled Trials and Comparative Effectiveness Research. Journal of Clinical Oncology, 30, 4194-4201. https://doi.org/10.1200/jco.2012.42.2352
[30]
Loudon, K., Treweek, S., Sullivan, F., Donnan, P., Thorpe, K.E. and Zwarenstein, M. (2015) The PRECIS-2 Tool: Designing Trials That Are Fit for Purpose. BMJ, 350, h2147. https://doi.org/10.1136/bmj.h2147
[31]
Markle-Reid, M., Ploeg, J., Fraser, K.D., Fisher, K.A., Akhtar-Danesh, N., Bartholomew, A., et al. (2017) The ACHRU-CPP versus Usual Care for Older Adults with Type-2 Diabetes and Multiple Chronic Conditions and Their Family Caregivers: Study Protocol for a Randomized Controlled Trial. Trials, 18, Article No. 55. https://doi.org/10.1186/s13063-017-1795-9
[32]
Ware, J.E., Kosinski, M. and Keller, S.D. (1996) A 12-Item Short-Form Health Survey. Medical Care, 34, 220-233. https://doi.org/10.1097/00005650-199603000-00003
[33]
Toobert, D.J., Hampson, S.E. and Glasgow, R.E. (2000) The Summary of Diabetes Self-Care Activities Measure: Results from 7 Studies and a Revised Scale. Diabetes Care, 23, 943-950. https://doi.org/10.2337/diacare.23.7.943
[34]
Radloff, L.S. (1977) The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement, 1, 385-401. https://doi.org/10.1177/014662167700100306
[35]
Spitzer, R.L., Kroenke, K., Williams, J.B.W. and L？we, B. (2006) A Brief Measure for Assessing Generalized Anxiety Disorder. Archives of Internal Medicine, 166, 1092-1097. https://doi.org/10.1001/archinte.166.10.1092
[36]
Koenig, H.G., Westlund, R.E., George, L.K., Hughes, D.C., Blazer, D.G. and Hybels, C. (1993) Abbreviating the Duke Social Support Index for Use in Chronically Ill Elderly Individuals. Psychosomatics, 34, 61-69. https://doi.org/10.1016/s0033-3182(93)71928-3
[37]
Keller, H.H., Goy, R. and Kane, S.L. (2005) Validity and Reliability of SCREEN II (Seniors in the Community: Risk Evaluation for Eating and Nutrition, Version II). European Journal of Clinical Nutrition, 59, 1149-1157. https://doi.org/10.1038/sj.ejcn.1602225
[38]
Washburn, R.A., Smith, K.W., Jette, A.M. and Janney, C.A. (1993) The Physical Activity Scale for the Elderly (PASE): Development and Evaluation. Journal of Clinical Epidemiology, 46, 153-162. https://doi.org/10.1016/0895-4356(93)90053-4
[39]
Fillenbaum, G.G. and Smyer, M.A. (1981) The Development, Validity, and Reliability of the Oars Multidimensional Functional Assessment Questionnaire. Journal of Gerontology, 36, 428-434. https://doi.org/10.1093/geronj/36.4.428
[40]
Elwyn, G., Barr, P.J., Grande, S.W., Thompson, R., Walsh, T. and Ozanne, E.M. (2013) Developing Collaborate: A Fast and Frugal Patient-Reported Measure of Shared Decision Making in Clinical Encounters. Patient Education and Counseling, 93, 102-107. https://doi.org/10.1016/j.pec.2013.05.009
[41]
Browne, G., Gafni, A. and Roberts, J. (2006) Approach to the Measurement of Resource Use and Costs. McMaster University, System-Linked Research Unit on Health and Social Service Utilization. https://macsphere.mcmaster.ca/home
[42]
Markle-Reid, M., Gafni, A., Ploeg, J., Fisher, K. and Ark, P. (2015) Health and Social Service Utilization Costing Manual. Aging, Community and Health Research Unit, McMaster University, Hamilton. https://achru.mcmaster.ca/
[43]
Thornton, M. and Travis, S.S. (2003) Analysis of the Reliability of the Modified Caregiver Strain Index. The Journals of Gerontology Series B: Psychological Sciences and Social Sciences, 58, S127-S132. https://doi.org/10.1093/geronb/58.2.s127
[44]
Austin, P.C., White, I.R., Lee, D.S. and van Buuren, S. (2021) Missing Data in Clinical Research: A Tutorial on Multiple Imputation. Canadian Journal of Cardiology, 37, 1322-1331. https://doi.org/10.1016/j.cjca.2020.11.010
[45]
Rubin, D.B. (1987) Multiple Imputation for Nonresponse in Surveys. Wiley. https://doi.org/10.1002/9780470316696
[46]
Schafer, J.L. (1999) Multiple Imputation: A Primer. Statistical Methods in Medical Research, 8, 3-15. https://doi.org/10.1177/096228029900800102
[47]
Rao, S., Dimitropoulos, G., Williams, J.V.A., Sharifi, V., Fahim, M., Munir, A., et al. (2024) Associations between Negative COVID-19 Experiences and Symptoms of Anxiety and Depression: A Study Based on a Representative Canadian National Sample. Health Promotion and Chronic Disease Prevention in Canada, 44, 56-65. https://doi.org/10.24095/hpcdp.44.2.03
[48]
Hansel, T.C., Saltzman, L.Y., Melton, P.A., Clark, T.L. and Bordnick, P.S. (2022) COVID-19 Behavioral Health and Quality of Life. Scientific Reports, 12, Article No. 961. https://doi.org/10.1038/s41598-022-05042-z
[49]
Massazza, A., Roberts, B., Fuhr, D.C., Woodward, A., Park, A., Sondorp, E., et al. (2023) A Qualitative Study on the Impacts of COVID-19 on the Delivery of Randomised Controlled Trials Evaluating Lay-Delivered Psychological Interventions in Five Countries. SSM-Mental Health, 4, Article 100251. https://doi.org/10.1016/j.ssmmh.2023.100251
[50]
Hopman, W.M., Towheed, T., Anastassiades, T., Tenenhouse, A., Poliquin, S., Berger, C., et al. (2000) Canadian Normative Data for the SF-36 Health Survey. Canadian Medical Association Journal, 163, 265-271.
[51]
Smith, S.M., Wallace, E., Salisbury, C., Sasseville, M., Bayliss, E. and Fortin, M. (2018) A Core Outcome Set for Multimorbidity Research (COSmm). The Annals of Family Medicine, 16, 132-138. https://doi.org/10.1370/afm.2178
[52]
McQueen, A., von Nordheim, D., Caburnay, C., Li, L., Herrick, C., Grimes, L., et al. (2024) A Randomized Controlled Trial Testing the Effects of a Social Needs Navigation Intervention on Health Outcomes and Healthcare Utilization among Medicaid Members with Type 2 Diabetes. International Journal of Environmental Research and Public Health, 21, Article 936. https://doi.org/10.3390/ijerph21070936
[53]
Cheng, A.Y.Y., Harris, S., Krawchenko, I., Tytus, R., Hahn, J., Liu, A., et al. (2023) Impact of the COVID-19 Pandemic on Adults with Type 2 Diabetes Care and Clinical Parameters in a Primary Care Setting in Ontario, Canada: A Cross-Sectional Study. Canadian Journal of Diabetes, 47, 345-351. https://doi.org/10.1016/j.jcjd.2023.01.003
[54]
Oviedo, S.A., McDonald, B., Gander, J.C., Ali, M.K. and Harding, J.L. (2024) Access to Telehealth and Changes in Diabetes Care Patterns during the Pandemic: Evidence from a Large Integrated Health System in the Southeast Usa. BMJ Open Diabetes Research & Care, 12, e003882. https://doi.org/10.1136/bmjdrc-2023-003882
[55]
Alessi, J., de Oliveira, G.B., Franco, D.W., Becker, A.S., Knijnik, C.P., Kobe, G.L., et al. (2021) Telehealth Strategy to Mitigate the Negative Psychological Impact of the COVID-19 Pandemic on Type 2 Diabetes: A Randomized Controlled Trial. Acta Diabetologica, 58, 899-909. https://doi.org/10.1007/s00592-021-01690-1
[56]
Rosta, L., Menyhart, A., Mahmeed, W.A., Al-Rasadi, K., Al-Alawi, K., Banach, M., et al. (2023) Telemedicine for Diabetes Management during COVID-19: What We Have Learnt, What and How to Implement. Frontiers in Endocrinology, 14, Article ID: 1129793. https://doi.org/10.3389/fendo.2023.1129793
[57]
Zhang, B. (2021) Expert Consensus on Telemedicine Management of Diabetes (2020 Edition). International Journal of Endocrinology, 2021, Article ID: 6643491. https://doi.org/10.1155/2021/6643491
[58]
Smith, S.M., Wallace, E., O’Dowd, T. and Fortin, M. (2016) Interventions for Improving Outcomes in Patients with Multimorbidity in Primary Care and Community Settings. Cochrane Database of Systematic Reviews, No. 3, CD006560. https://doi.org/10.1002/14651858.cd006560.pub3
[59]
Boult, C., Leff, B., Boyd, C.M., Wolff, J.L., Marsteller, J.A., Frick, K.D., et al. (2013) A Matched-Pair Cluster-Randomized Trial of Guided Care for High-Risk Older Patients. Journal of General Internal Medicine, 28, 612-621. https://doi.org/10.1007/s11606-012-2287-y
[60]
Yous, M., Ganann, R., Ploeg, J., Markle-Reid, M., Northwood, M., Fisher, K., et al. (2023) Older Adults’ Experiences and Perceived Impacts of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP) for Diabetes Self-Management in Canada: A Qualitative Descriptive Study. BMJ Open, 13, e068694. https://doi.org/10.1136/bmjopen-2022-068694
[61]
Salisbury, C., Man, M., Bower, P., Guthrie, B., Chaplin, K., Gaunt, D.M., et al. (2018) Management of Multimorbidity Using a Patient-Centred Care Model: A Pragmatic Cluster-Randomised Trial of the 3D Approach. The Lancet, 392, 41-50. https://doi.org/10.1016/s0140-6736(18)31308-4
[62]
Sikka, R., Morath, J.M. and Leape, L. (2015) The Quadruple Aim: Care, Health, Cost and Meaning in Work. BMJ Quality & Safety, 24, 608-610. https://doi.org/10.1136/bmjqs-2015-004160
