NCT02158741

Brief Summary

The overall purpose of this research is to examine and compare the effectiveness and costs of a community-based intervention to support self-management with usual primary care for older adults with Type 2 Diabetes Mellitus and multiple chronic conditions and their family caregivers. Once the study is complete, the investigators will be able to determine if there is any measurable difference in self-care management between usual care plus the intervention versus usual care alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

June 3, 2014

Last Update Submit

August 28, 2019

Conditions

Type 2 Diabetes MellitusNIDDMNon-insulin Dependent Diabetes Mellitus

Keywords

Self-ManagementHome Visits

Outcome Measures

Primary Outcomes (1)

  • Summary of Diabetes Self-Care Activities

    The SDSCA is a multidimensional measure of diabetes self-management with adequate internal and test-retest reliability, and evidence of validity and sensitivity to change. The revised SDSCA consists of items that assess the following aspects of the diabetes regimen: general and specific diet, exercise, blood-glucose testing, foot care, and smoking. Scores are calculated for each of these five regimen areas. This data is collected by the interventionists at each visit.

    Every two months from study onset until the end of study (6 months from baseline)

Secondary Outcomes (1)

  • SF12v2

    Baseline and end of study (6 months from baseline)

Other Outcomes (3)

  • CES-D-10

    Baseline and end of study (6 months from baseline)

  • GAD-7

    Baseline and end of study (6 months from baseline)

  • Health Assessment forms

    Baseline intervention interview, at 3 months and again at 6 months

Study Arms (2)

Usual Primary Care

NO INTERVENTION

Usual Primary Care will be received by half the participants during the course of the Study

Home Visits and educational support

ACTIVE COMPARATOR

Intervention comprised of Home Visits and group educational sessions. Home Visits and will be conducted by Diabetes Education staff in lieu of usual care conducted at the Diabetes clinic. Lifestyle support and educational will be offered in the form of monthly Diabetes Wellness Days offered in the community where nutrition, exercise and support will be given to help improve self-management of diabetes.

Behavioral: Home Visits and Lifestyle Education Support

Interventions

Home Visits and Lifestyle Education SupportBEHAVIORAL
Home Visits and educational support

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • older adults aged 65+
  • live in the local vicinity of a participating Diabetes Education Program
  • were referred to their Diabetes Education Program within the past 24 months
  • competence in English (or access to a translator)
  • intention to continue living in the area for the next 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Edmonton Oliver PCN

Edmonton, Alberta, Canada

Location

Leduc Beaumont Devon PCN

Leduc, Alberta, T9E 6W2, Canada

Location

Sherwood Park PCN

Sherwood Park, Alberta, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Ross Memorial Hospital

Lindsay, Ontario, Canada

Location

St. Joseph's Health Care

London, Ontario, Canada

Location

Peterborough Regional Health Centre

Peterborough, Ontario, Canada

Location

Port Hope Community Health Centre

Port Hope, Ontario, Canada

Location

Related Publications (4)

  • Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Bartholomew A, Griffith LE, Miklavcic J, Gafni A, Thabane L, Upshur R. Community Program Improves Quality of Life and Self-Management in Older Adults with Diabetes Mellitus and Comorbidity. J Am Geriatr Soc. 2018 Feb;66(2):263-273. doi: 10.1111/jgs.15173. Epub 2017 Nov 27.

    PMID: 29178317RESULT

  • Miklavcic JJ, Fraser KD, Ploeg J, Markle-Reid M, Fisher K, Gafni A, Griffith LE, Hirst S, Sadowski CA, Thabane L, Triscott JAC, Upshur R. Effectiveness of a community program for older adults with type 2 diabetes and multimorbidity: a pragmatic randomized controlled trial. BMC Geriatr. 2020 May 13;20(1):174. doi: 10.1186/s12877-020-01557-0.

    PMID: 32404059DERIVED

  • Markle-Reid M, Ploeg J, Valaitis R, Duggleby W, Fisher K, Fraser K, Ganann R, Griffith LE, Gruneir A, McAiney C, Williams A. Protocol for a program of research from the Aging, Community and Health Research Unit: Promoting optimal aging at home for older adults with multimorbidity. J Comorb. 2018 Jul 31;8(1):2235042X18789508. doi: 10.1177/2235042X18789508. eCollection 2018.

    PMID: 30191144DERIVED

  • Markle-Reid M, Ploeg J, Fraser KD, Fisher KA, Akhtar-Danesh N, Bartholomew A, Gafni A, Gruneir A, Hirst SP, Kaasalainen S, Stradiotto CK, Miklavcic J, Rojas-Fernandez C, Sadowski CA, Thabane L, Triscott JA, Upshur R. 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. 2017 Feb 6;18(1):55. doi: 10.1186/s13063-017-1795-9.

    PMID: 28166816DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

House Calls

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Maureen Markle-Reid, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Jenny Ploeg, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, PhD, Scientific Director

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 9, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

CA(8)