NCT01486290

Brief Summary

The purpose of this study is to find ways to identify barriers that affect self care in older adult with diabetes and to provide cost effective coping strategies to improve clinical, functional and psychosocial measures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

July 1, 2007

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 28, 2014

Status Verified

March 1, 2014

Enrollment Period

5.4 years

First QC Date

November 23, 2011

Last Update Submit

March 26, 2014

Conditions

Diabetes

Keywords

InterventionCost EffectiveElderlyGlycemic Control

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    The primary outcomes of the study is to measure change in A1c before and after intervention.

    6 and 12 months

Secondary Outcomes (7)

  • Hypoglycemia

    6 and 12 months

  • functionality

    6 and 12 months

  • Cognitive function

    6 and 12 months

  • Depression

    6 and 12 months

  • Self care inventory - revised

    6 and 12 months

  • +2 more secondary outcomes

Study Arms (2)

Geriatric Diabetes Team Intervention

EXPERIMENTAL

The subjects in this group underwent evaluation for barriers to self care by a diabetes educator well versed with age specific barriers. After consideration of patient clinical, function, and psychosocial background, a geriatric diabetes team devised strategy to help patients cope with respective barriers. An office based diabetes diabetes educator conveyed the strategy to patient and caregivers viz phone calls. the educator called study participants up wot eleven times over a sex month period.

Behavioral: Behavioral

Atention Control Arm

NO INTERVENTION

The subjects in the group received similar, in person contact, as the intervention group. an educator, separate from the one involved in the intervention team, called patients in this group for a total of eleven times within the first six months. The Phone calls were focused toward general discussion without any diabetes related advice.

Interventions

BehavioralBEHAVIORAL

the intervention included developing strategies to help patients cope with their barriers to self care. The intervention were implemented by an office based educator over a six month by phone calls. From six months to twelve months subjects did not have any contact with study staff.

Also known as: Clinical, Education, Nutrition, Care coordination
Geriatric Diabetes Team Intervention

Eligibility Criteria

Age69 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 70 years and older
  • Diagnosis of type 1 or type 2 diabetes
  • Seen at Joslin Clinic or Beth Israel Deaconess Medical Center for at least one year
  • HbA1c 8% X 2 in past 6 months without fluctuation of more than 0.5% (i.e. stable poor control)
  • No major change in medications in past 3 months, e.g. addition of insulin or another hypoglycemic agent

You may not qualify if:

  • Patients with terminal diseases, e.g. malignancy with expected life expectancy of 12 months or less
  • Patients who live more than 25 miles from Joslin Clinic/Beth Israel Deaconess Medical Center
  • Patients who live in an institutional setting (e.g. nursing home, group home, etc)
  • Patients who are not able to complete outcome assessments, (e.g. poor vision, diminished mental capacity/severe cognitive decline, unable to speak/read/write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (34)

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    PMID: 23193208DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational StatusNutritional Status

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemography

Study Officials

  • Medha N Munshi, MD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Geriactric Diabetes Clinic

Study Record Dates

First Submitted

November 23, 2011

First Posted

December 6, 2011

Study Start

July 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 28, 2014

Record last verified: 2014-03

Locations

US(1)