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Diabetes MellitusQUALITYHF-DMNCT01606085

Cost Effectiveness and Quality of Life in Heart Failure Patients With Diabetes

A study testing HF DM self care in people with Diabetes Mellitus and Heart Failure, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purposes of this study are: 1. to develop and test an integrated self care intervention for Heart Failure (HF)patients with Diabetes (DM) for its effects on patient outcomes including health related quality of life (HRQOL), physical function and health resource utilization. 2. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Diabetes Mellitus, Heart Failure
What is being tested?
HF DM self care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
141 participants
Where
1 siteUnited States
Study dates
Sep 2009to Apr 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • hospital admission with a diagnosis of Heart Failure (HF) with Left Ventricular Systolic Dysfunction (LVSD) or diastolic dysfunction and concomitant Diabetes (DM) type II
  • planned discharge from hospital to home setting
  • NYHA Class II-IV
  • On optimal HF regimen of care including ACE-Inhibitors or ARBs beta blocking agents, and diuretics if indicated by patient fluid status
  • ambulatory
  • able to read and write English
  • acceptable cognitive screening test

Who cannot join

  • planned discharge to long term acute care
  • presence of an insulin pump
  • active foot ulcer
  • presence of hemodynamically significant angina pectoris
  • renal failure with hemodialysis
  • planned cardiac surgery
Show all 13Show fewer
  • impaired cognition due to neurological comorbidity
  • psychiatric diagnosis
  • uncorrected visual or hearing problem
  • uncorrected hearing or vision problems
  • moderately severe depressive symptoms
  • UNOS/ A status or ventricular assist device
  • lack of telephone access

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory University School of Nursing

    Atlanta, Georgia, 30322

Other trials in United States

About this study

The purposes of this study are:

  1. to develop and test an integrated self care intervention for Heart Failure (HF)patients with Diabetes (DM) for its effects on patient outcomes including health related quality of life (HRQOL), physical function and health resource utilization.
  2. to assess the costs and cost effectiveness of the intervention.

The intervention is designed to go beyond usual care of providing separate Heart Failure (HF) and Diabetes (DM) patient education by educating HF-DM patients on integrated self care and self management related to a HF-DM diet, HF-DM medication-taking behaviors, physical activity, and HF-DM symptom monitoring and management. An integrated self care intervention will compare HF-DM patients who receive the intervention with those who receive usual care-attention control for effects on patient outcomes,self care process measures, and health care utilization. If effective, the intervention will lead to improved self care, improved quality of life, and reduced health care resource use and costs. This study will facilitate greater understanding of self care within the context of two chronic illnesses and will lead directly to improved clinical practice and future research on comorbid self care in Heart Failure.

Read the detailed description

The investigators hypothesize that participants receiving the Heart Failure and Diabetes (HF-DM) self-care intervention will report greater Health Related Quality of Life (HRQOL) on the Minnesota Living with HF Questionnaire (MLHFQ), the Audit of Diabetes-dependent Quality of Life (ADDQoL), and the EuroQol (EQ5D) than the Usual Care (UC-AC) group at 6 months when controlling for age, gender, and NYHA Class.

Secondly, that participants receiving the Heart Failure and Diabetes (HF-DM) self-care intervention will demonstrate improved physical function indicators (BNP levels, HgA1c, and 6MWT) at 6 months over the UC-AC group when controlling for age, gender, BMI, and NYHA Class and comorbid conditions.

Thirdly, that participants receiving the Heart Failure and Diabetes (HF-DM) self-care intervention will exhibit greater improvement in: HF knowledge and DM knowledge than UC-AC at 6 months. Participants receiving the integrated HF-DM self-care intervention will report greater improvements in HF self-efficacy and DM self-efficacy over UC-AC at 6 months. HF-DM patients randomized to the integrated self-care intervention will exhibit greater improvements in overall HF and DM self-care behaviors and HF-DM diet and physical activity over UC-AC at 6 months.

Lastly, that HF-DM patients who receive the integrated self-care intervention will exhibit less health resource use and associated costs(direct health care costs of provider visits, hospitalizations, ED visits, length of stay, and direct non-health care costs associated with the HRU and intervention) over the 6 months than those who receive UC-AC controlling for comorbidity and insurance status.

Being tested
HF DM self care, Usual Care
Keywords
Diabetes, Heart Failure, Quality of Life, Self Care
Medical subject headings
Diabetes Mellitus, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HF DM self careBehavioural

    Also called HF-DM Self Care

    Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction

  • Usual CareBehavioural

    Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study.

Study groups in NCT01606085
Study groupRoleWhat they receive
HF-DM Self CareExperimentaleducational counseling intervention about integrated HF-DM self care outcomes
Receives: Behavioral: HF DM self care; Behavioral: Usual Care
Usual CareNo interventionUsual Care provided by providers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart failure health related quality of life measures

    As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ).

    Measured: 6 months

  2. Diabetes health related quality of life measures

    As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL).

    Measured: 6 months

Secondary outcomes (7)

  1. Heart Failure and Diabetes (HF-DM) physical outcomes

    BNP and HgA1c, and 6 minute walk test

    Measured: 6 months

  2. Heart Failure Knowledge

    As measured by the Atlanta Heart Failure Knowledge Test (AHFKT)

    Measured: 6 months

  3. Health resource use

    As measured by hospital and ED visits as well as contact with medical providers

    Measured: 6 months

  4. Heart Failure (HF) self-efficacy

    As measured by Self Care in Heart Failure Inventory Self Efficacy Scale

    Measured: 6 months

  5. Heart Failure and Diabetes(HF-DM) self-care behaviors

    As measured by activity calendars/logs, Self care in Heart failure Inventory subscales, and Summary of Diabetes Self Care Scale

    Measured: 6 months

  6. Diabetes (DM) Knowledge

    Michigan Diabetes Knowledge Test (MDKT)

    Measured: 6 months

  7. Diabetes (DM) self efficacy

    Measured by the Perceived Diabetes Self Management Scale (PDSMS)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2012 (estimated)
  2. Study startSep 2009
  3. Primary completionSep 2013
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01606085
Sponsor's protocol ID
IRB00026671
Other IDs
1R01NR011888-01
Acronym
QUALITYHF-DM
Status last verified
Sep 2013
First submitted
14 May 2012
Last updated
24 Apr 2014
Results posted
No
Data monitoring committee
No

Publications

  • Reilly CM, Butler J, Culler SD, Gary RA, Higgins M, Schindler P, Butts B, Dunbar SB. An economic evaluation of a self-care intervention in persons with heart failure and diabetes. J Card Fail. 2015 Sep;21(9):730-7. doi: 10.1016/j.cardfail.2015.06.382. Epub 2015 Jul 8.

    PubMed 26164214

  • Dunbar SB, Reilly CM, Gary R, Higgins MK, Culler S, Butts B, Butler J. Randomized clinical trial of an integrated self-care intervention for persons with heart failure and diabetes: quality of life and physical functioning outcomes. J Card Fail. 2015 Sep;21(9):719-29. doi: 10.1016/j.cardfail.2015.05.012. Epub 2015 May 29.

    PubMed 26028261

Questions about this trial

What is this clinical trial studying?

A study testing HF DM self care in people with Diabetes Mellitus and Heart Failure, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart failure health related quality of life measures (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01606085, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2014.

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QUALITYHF-DM Clinical Trial NCT01606085 | AzTrials