Evidence map›Paper›PMID 31193095›Full record

ArticleContemporary clinical trials communications2019

Effective recruitment for practice-based research: Lessons from the REAL HEALTH-Diabetes Study.

Valerie Goldman, Amy Dushkin, Deborah J Wexler, Yuchiao Chang, Bianca Porneala, Laurie Bissett, Jeanna McCarthy, Anthony Rodriguez, Barbara Chase, Rajani LaRocca and 2 more

Registry-linked trialAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02320253 (REAL HEALTH-Diabetes), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02320253 nacompletednot on this map

REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes

TypeinterventionalSponsorMassachusetts General HospitalRan2014 to 2021Enrolled211ConditionsType 2 Diabetes Mellitus, ObesityArmsIn Person Group (IP), Telephone Conference Call Group (TCC), Medical Nutrition Therapy (MNT)
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

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  9. Intervening on Metabolic Dysfunction-Associated Steatotic Liver Disease in Latino/a and Black Patients with Diabetes: A Feasibility Pilot.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Valerie GoldmanMassachusetts General Hospital (MGH) Diabetes Research Center, MGH Diabetes Unit, Department of Medicine, Boston, MA, USA.
Amy DushkinMassachusetts General Hospital (MGH) Diabetes Research Center, MGH Diabetes Unit, Department of Medicine, Boston, MA, USA.
Deborah J WexlerMassachusetts General Hospital (MGH) Diabetes Research Center, MGH Diabetes Unit, Department of Medicine, Boston, MA, USA.
Yuchiao ChangDivision of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.
Bianca PornealaDivision of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.
Laurie BissettMassachusetts General Hospital (MGH) Diabetes Research Center, MGH Diabetes Unit, Department of Medicine, Boston, MA, USA.
Jeanna McCarthyMassachusetts General Hospital (MGH) Diabetes Research Center, MGH Diabetes Unit, Department of Medicine, Boston, MA, USA.
Anthony RodriguezMassachusetts General Hospital (MGH) Diabetes Research Center, MGH Diabetes Unit, Department of Medicine, Boston, MA, USA.
Barbara ChaseDivision of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA.
Rajani LaRoccaHarvard Medical School, Boston, MA, USA.
Amy WheelerHarvard Medical School, Boston, MA, USA.
Linda M DelahantyMassachusetts General Hospital (MGH) Diabetes Research Center, MGH Diabetes Unit, Department of Medicine, Boston, MA, USA.

Funding

REAL HEALTH-Diabetes: REach Ahead for Lifestyle and Health-DiabetesR18DK102737 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI DELAHANTY, LINDA MICHELE, WEXLER, DEBORAH J · 2014 to 2018
$3.2M
NIDDK NIH HHS R18 DK102737
6 · The paper itself

Abstract

backgroundAims: The REAL HEALTH Diabetes Study is a practice-based randomized clinical trial that compares the effectiveness of lifestyle intervention aimed at weight reduction to medical nutrition therapy in primary care patients with type 2 diabetes. This paper describes a tiered approach to recruitment, the resultant enrollment rates of sequentially more intensive recruitment strategies, and identifies barriers to participation.

methodsPotential participants were identified using patient health registries and classified by recruitment site. Four recruitment strategies were used to achieve target enrollment: (1) mail/telephone outreach; (2) direct referral from providers; (3) orientation sessions; and (4) media/advertising. Reasons for ineligibility and non-participation were tracked.

resultsFifteen thousand two hundred sixty-nine (15,269) potential participants were identified from all sources, with the clear majority coming from patient registries. Mail/telephone outreach alone had the lowest enrollment rate (1.2%). Direct referral and orientation sessions superimposed on mail/telephone outreach was used for fewer participants but had greater enrollment rates (27% and 52%.) Media/advertising was ineffective. The most commonly reported reasons for non-participation were not wanting to be in a research (30%) or a weight loss program (22%); time commitment (20%); and distance/transportation (14%).

conclusionsThe use of population registries to identify potential participants coupled with successively more intensive recruitment strategies, executed in a tiered approach moving toward personal engagement to establish trust and credibility, maximized recruitment enrollment rates. Our findings regarding facilitators and barriers to recruitment could be used to inform other practice-based research or to engage patients in group interventions in usual care settings. CLINICAL

trial registrationNCT02320253.

Indexed as

Complex behavioral interventionLifestyle interventionPopulation health registriesPractice-based clinical trialPractice-based researchPrimary careRecruitment strategiesWeight loss interventions

Identifiers

PMID31193095
PMCPMC6517530

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.