A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes
Background Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management. Objective Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual...
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| Veröffentlicht in: | Journal of general internal medicine : JGIM 2024-10, Vol.39 (13), p.2415-2424 |
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| creator | Patel, Minal R. Zhang, Guanghao Heisler, Michele Piette, John D. Resnicow, Kenneth Choe, Hae-Mi Shi, Xu Song, Peter |
| description | Background
Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management.
Objective
Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual care.
Design
Randomized trial from 2019 to 2023.
Participants
A total of 600 adults with diabetes, HbA1c ≥ 7.5%, and self-reported unmet social needs or financial burden from a health system and randomized to the intervention or standard care.
Intervention
CareAvenue is an automated, e-health intervention with eight videos that address unmet social needs contributing to poor outcomes.
Measures
Primary outcome was HbA1c, measured at baseline, and 6 and 12 months after randomization. Secondary outcomes included systolic blood pressure and reported met social needs, cost-related non-adherence (CRN), and financial burden. We examined main effects and variation in effects across predefined subgroups.
Results
Seventy-eight percent of CareAvenue participants completed one or more modules of the website. At 12-month follow-up, there were no significant differences in HbA1c changes between CareAvenue and control group (
p
= 0.24). There were also no significant between-group differences in systolic blood pressure (
p
= 0.29), met social needs (
p
= 0.25), CRN (
p
= 0.18), and perceived financial burden (
p
= 0.31). In subgroup analyses, participants with household incomes 100–400% FPL (1.93 (SE = 0.76),
p
|
| doi_str_mv | 10.1007/s11606-024-08708-8 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2956159237</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3110554556</sourcerecordid><originalsourceid>FETCH-LOGICAL-c326t-7fcb97182a351377801470b887e86c78e4afaa1361583a06c31ee7013b967ccd3</originalsourceid><addsrcrecordid>eNp9kU9PFTEUxRuikSfwBViYJm7YjPa20z-zfHkKkhBJFNZNp3MfDulMse1o4NNTfKiJC1dtbn_n9N57CDkG9g4Y0-8zgGKqYbxtmNHMNGaPrEBy2UDb6RdkxYxpG6NFu09e53zLGAjOzSuyL0yrdAdmRcKafnHzEKfxAQe6iXNJMYR6vUqjC7REej7dpfgD6fU8YaFfo3-qf0YcMq1CugnjPPpaulyKjxNmup7ifEPXwxJKpj_H8o1-GF2PBfMhebl1IePR83lArk8_Xm0-NReXZ-eb9UXjBVel0VvfdxoMd0KC0NowaDXrjdFolNcGW7d1DoQCaYRjygtA1HW4vlPa-0EckJOdb-38-4K52GnMHkNwM8YlW97Jqu240BV9-w96G5c01-6sAGBStlKqSvEd5VPMOeHW3qVxcuneArNPWdhdFrZmYX9lYU0VvXm2XvoJhz-S38uvgNgBuT7NN5j-_v0f20dyfJL6</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3110554556</pqid></control><display><type>article</type><title>A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes</title><source>SpringerLink Journals - AutoHoldings</source><creator>Patel, Minal R. ; Zhang, Guanghao ; Heisler, Michele ; Piette, John D. ; Resnicow, Kenneth ; Choe, Hae-Mi ; Shi, Xu ; Song, Peter</creator><creatorcontrib>Patel, Minal R. ; Zhang, Guanghao ; Heisler, Michele ; Piette, John D. ; Resnicow, Kenneth ; Choe, Hae-Mi ; Shi, Xu ; Song, Peter</creatorcontrib><description>Background
Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management.
Objective
Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual care.
Design
Randomized trial from 2019 to 2023.
Participants
A total of 600 adults with diabetes, HbA1c ≥ 7.5%, and self-reported unmet social needs or financial burden from a health system and randomized to the intervention or standard care.
Intervention
CareAvenue is an automated, e-health intervention with eight videos that address unmet social needs contributing to poor outcomes.
Measures
Primary outcome was HbA1c, measured at baseline, and 6 and 12 months after randomization. Secondary outcomes included systolic blood pressure and reported met social needs, cost-related non-adherence (CRN), and financial burden. We examined main effects and variation in effects across predefined subgroups.
Results
Seventy-eight percent of CareAvenue participants completed one or more modules of the website. At 12-month follow-up, there were no significant differences in HbA1c changes between CareAvenue and control group (
p
= 0.24). There were also no significant between-group differences in systolic blood pressure (
p
= 0.29), met social needs (
p
= 0.25), CRN (
p
= 0.18), and perceived financial burden (
p
= 0.31). In subgroup analyses, participants with household incomes 100–400% FPL (1.93 (SE = 0.76),
p
< 0.01), 201–400% FPL (1.30 (SE = 0.62),
p
< 0.04), and > 400% FPL (1.27 (SE = 0.64),
p
< 0.05) had significantly less A1c decreases compared to the control group.
Conclusions
On average, CareAvenue participants did not achieve better A1c lowering, met needs, CRN, or perceived financial burden compared to control participants. CareAvenue participants with higher incomes achieved significantly less A1c reductions than control. Further research is needed on social needs interventions that consider tailored approaches to population subgroups.
Clinical Trials Registry
ClinicalTrials.gov ID NCT03950973, May 2019.</description><identifier>ISSN: 0884-8734</identifier><identifier>ISSN: 1525-1497</identifier><identifier>EISSN: 1525-1497</identifier><identifier>DOI: 10.1007/s11606-024-08708-8</identifier><identifier>PMID: 38467918</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adults ; Blood pressure ; Clinical outcomes ; Clinical trials ; Diabetes ; Diabetes mellitus (insulin dependent) ; Diabetes mellitus (non-insulin dependent) ; Financial management ; Health promotion ; Internal Medicine ; Intervention ; Medicine ; Medicine & Public Health ; Original Research ; Randomization ; Socioeconomic factors ; Subgroups</subject><ispartof>Journal of general internal medicine : JGIM, 2024-10, Vol.39 (13), p.2415-2424</ispartof><rights>The Author(s), under exclusive licence to Society of General Internal Medicine 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2024. The Author(s), under exclusive licence to Society of General Internal Medicine.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c326t-7fcb97182a351377801470b887e86c78e4afaa1361583a06c31ee7013b967ccd3</cites><orcidid>0000-0002-3400-5155</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11606-024-08708-8$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11606-024-08708-8$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38467918$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Patel, Minal R.</creatorcontrib><creatorcontrib>Zhang, Guanghao</creatorcontrib><creatorcontrib>Heisler, Michele</creatorcontrib><creatorcontrib>Piette, John D.</creatorcontrib><creatorcontrib>Resnicow, Kenneth</creatorcontrib><creatorcontrib>Choe, Hae-Mi</creatorcontrib><creatorcontrib>Shi, Xu</creatorcontrib><creatorcontrib>Song, Peter</creatorcontrib><title>A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes</title><title>Journal of general internal medicine : JGIM</title><addtitle>J GEN INTERN MED</addtitle><addtitle>J Gen Intern Med</addtitle><description>Background
Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management.
Objective
Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual care.
Design
Randomized trial from 2019 to 2023.
Participants
A total of 600 adults with diabetes, HbA1c ≥ 7.5%, and self-reported unmet social needs or financial burden from a health system and randomized to the intervention or standard care.
Intervention
CareAvenue is an automated, e-health intervention with eight videos that address unmet social needs contributing to poor outcomes.
Measures
Primary outcome was HbA1c, measured at baseline, and 6 and 12 months after randomization. Secondary outcomes included systolic blood pressure and reported met social needs, cost-related non-adherence (CRN), and financial burden. We examined main effects and variation in effects across predefined subgroups.
Results
Seventy-eight percent of CareAvenue participants completed one or more modules of the website. At 12-month follow-up, there were no significant differences in HbA1c changes between CareAvenue and control group (
p
= 0.24). There were also no significant between-group differences in systolic blood pressure (
p
= 0.29), met social needs (
p
= 0.25), CRN (
p
= 0.18), and perceived financial burden (
p
= 0.31). In subgroup analyses, participants with household incomes 100–400% FPL (1.93 (SE = 0.76),
p
< 0.01), 201–400% FPL (1.30 (SE = 0.62),
p
< 0.04), and > 400% FPL (1.27 (SE = 0.64),
p
< 0.05) had significantly less A1c decreases compared to the control group.
Conclusions
On average, CareAvenue participants did not achieve better A1c lowering, met needs, CRN, or perceived financial burden compared to control participants. CareAvenue participants with higher incomes achieved significantly less A1c reductions than control. Further research is needed on social needs interventions that consider tailored approaches to population subgroups.
Clinical Trials Registry
ClinicalTrials.gov ID NCT03950973, May 2019.</description><subject>Adults</subject><subject>Blood pressure</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes mellitus (insulin dependent)</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Financial management</subject><subject>Health promotion</subject><subject>Internal Medicine</subject><subject>Intervention</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Original Research</subject><subject>Randomization</subject><subject>Socioeconomic factors</subject><subject>Subgroups</subject><issn>0884-8734</issn><issn>1525-1497</issn><issn>1525-1497</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9kU9PFTEUxRuikSfwBViYJm7YjPa20z-zfHkKkhBJFNZNp3MfDulMse1o4NNTfKiJC1dtbn_n9N57CDkG9g4Y0-8zgGKqYbxtmNHMNGaPrEBy2UDb6RdkxYxpG6NFu09e53zLGAjOzSuyL0yrdAdmRcKafnHzEKfxAQe6iXNJMYR6vUqjC7REej7dpfgD6fU8YaFfo3-qf0YcMq1CugnjPPpaulyKjxNmup7ifEPXwxJKpj_H8o1-GF2PBfMhebl1IePR83lArk8_Xm0-NReXZ-eb9UXjBVel0VvfdxoMd0KC0NowaDXrjdFolNcGW7d1DoQCaYRjygtA1HW4vlPa-0EckJOdb-38-4K52GnMHkNwM8YlW97Jqu240BV9-w96G5c01-6sAGBStlKqSvEd5VPMOeHW3qVxcuneArNPWdhdFrZmYX9lYU0VvXm2XvoJhz-S38uvgNgBuT7NN5j-_v0f20dyfJL6</recordid><startdate>20241001</startdate><enddate>20241001</enddate><creator>Patel, Minal R.</creator><creator>Zhang, Guanghao</creator><creator>Heisler, Michele</creator><creator>Piette, John D.</creator><creator>Resnicow, Kenneth</creator><creator>Choe, Hae-Mi</creator><creator>Shi, Xu</creator><creator>Song, Peter</creator><general>Springer International Publishing</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-3400-5155</orcidid></search><sort><creationdate>20241001</creationdate><title>A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes</title><author>Patel, Minal R. ; Zhang, Guanghao ; Heisler, Michele ; Piette, John D. ; Resnicow, Kenneth ; Choe, Hae-Mi ; Shi, Xu ; Song, Peter</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c326t-7fcb97182a351377801470b887e86c78e4afaa1361583a06c31ee7013b967ccd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adults</topic><topic>Blood pressure</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes mellitus (insulin dependent)</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Financial management</topic><topic>Health promotion</topic><topic>Internal Medicine</topic><topic>Intervention</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Original Research</topic><topic>Randomization</topic><topic>Socioeconomic factors</topic><topic>Subgroups</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Patel, Minal R.</creatorcontrib><creatorcontrib>Zhang, Guanghao</creatorcontrib><creatorcontrib>Heisler, Michele</creatorcontrib><creatorcontrib>Piette, John D.</creatorcontrib><creatorcontrib>Resnicow, Kenneth</creatorcontrib><creatorcontrib>Choe, Hae-Mi</creatorcontrib><creatorcontrib>Shi, Xu</creatorcontrib><creatorcontrib>Song, Peter</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of general internal medicine : JGIM</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Patel, Minal R.</au><au>Zhang, Guanghao</au><au>Heisler, Michele</au><au>Piette, John D.</au><au>Resnicow, Kenneth</au><au>Choe, Hae-Mi</au><au>Shi, Xu</au><au>Song, Peter</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes</atitle><jtitle>Journal of general internal medicine : JGIM</jtitle><stitle>J GEN INTERN MED</stitle><addtitle>J Gen Intern Med</addtitle><date>2024-10-01</date><risdate>2024</risdate><volume>39</volume><issue>13</issue><spage>2415</spage><epage>2424</epage><pages>2415-2424</pages><issn>0884-8734</issn><issn>1525-1497</issn><eissn>1525-1497</eissn><abstract>Background
Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management.
Objective
Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual care.
Design
Randomized trial from 2019 to 2023.
Participants
A total of 600 adults with diabetes, HbA1c ≥ 7.5%, and self-reported unmet social needs or financial burden from a health system and randomized to the intervention or standard care.
Intervention
CareAvenue is an automated, e-health intervention with eight videos that address unmet social needs contributing to poor outcomes.
Measures
Primary outcome was HbA1c, measured at baseline, and 6 and 12 months after randomization. Secondary outcomes included systolic blood pressure and reported met social needs, cost-related non-adherence (CRN), and financial burden. We examined main effects and variation in effects across predefined subgroups.
Results
Seventy-eight percent of CareAvenue participants completed one or more modules of the website. At 12-month follow-up, there were no significant differences in HbA1c changes between CareAvenue and control group (
p
= 0.24). There were also no significant between-group differences in systolic blood pressure (
p
= 0.29), met social needs (
p
= 0.25), CRN (
p
= 0.18), and perceived financial burden (
p
= 0.31). In subgroup analyses, participants with household incomes 100–400% FPL (1.93 (SE = 0.76),
p
< 0.01), 201–400% FPL (1.30 (SE = 0.62),
p
< 0.04), and > 400% FPL (1.27 (SE = 0.64),
p
< 0.05) had significantly less A1c decreases compared to the control group.
Conclusions
On average, CareAvenue participants did not achieve better A1c lowering, met needs, CRN, or perceived financial burden compared to control participants. CareAvenue participants with higher incomes achieved significantly less A1c reductions than control. Further research is needed on social needs interventions that consider tailored approaches to population subgroups.
Clinical Trials Registry
ClinicalTrials.gov ID NCT03950973, May 2019.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>38467918</pmid><doi>10.1007/s11606-024-08708-8</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-3400-5155</orcidid></addata></record> |
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| ispartof | Journal of general internal medicine : JGIM, 2024-10, Vol.39 (13), p.2415-2424 |
| issn | 0884-8734 1525-1497 1525-1497 |
| language | eng |
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| source | SpringerLink Journals - AutoHoldings |
| subjects | Adults Blood pressure Clinical outcomes Clinical trials Diabetes Diabetes mellitus (insulin dependent) Diabetes mellitus (non-insulin dependent) Financial management Health promotion Internal Medicine Intervention Medicine Medicine & Public Health Original Research Randomization Socioeconomic factors Subgroups |
| title | A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes |
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