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Diabetes MellitusACTIVetNCT01671345

An Educational Intervention for Type 2 Diabetes Patients

A study testing Intervention Video in people with Diabetes Mellitus, run by VA Office of Research and Development 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

Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the prevalence of diabetes at almost 20 percent in VA patients and the prevalence of diabetes in the VA is higher among racial and ethnic minorities. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
Intervention Video
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
169 participants
Where
1 siteUnited States
Study dates
27 Nov 2013to 9 Jan 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of type 2 diabetes mellitus
  • Hemoglobin A1c (HgbA1c) greater than or equal to 8
  • Adults, age 18 or older

Who cannot join

  • Lives in skilled nursing facility
  • Dementia (abnormal score on Mini-COG)
  • Terminal medical condition
  • Drug- (e.g., steroid) induced diabetes.
  • Blind or deaf (e.g., unable to view/hear video)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jesse Brown VA Medical Center, Chicago, IL

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: A Randomized Trial of an Educational Intervention in Type 2 Diabetes Patients

Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the prevalence of diabetes at almost 20 percent in VA patients and the prevalence of diabetes in the VA is higher among racial and ethnic minorities. Poorly controlled diabetes leads to a number of complications including cardiovascular disease, blindness, amputation, and end stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care is related at least in part to effective communication in medical encounters. This project is designed to test a video intervention to improve patients' communication behaviors. Doctors will also receive a communication skills training program. The project will assess the impact of the training programs on communication and outcomes. The study is designed to help make patient care more patient-centered, which is one of the six aims for improvement in the Institute Of Medicine report, Crossing the Quality Chasm and is a goal of VA transformation efforts.

Read the detailed description

Background: Diabetes is estimated to affect up to 1 in 5 VA patients overall and up to 1 in 4 racial/ethnic minority patients. Patients with low health literacy and minority groups have more difficulty communicating with physicians, report lower adherence to physicians' recommendations, and have higher rates of poor diabetes outcomes. Activating patients to use more effective communication with physicians' can lead to better adherence to treatment and to better biomedical outcomes. In this project the investigators build upon their prior work from two Health Services Research \& Development (HSRD) funded pilot projects to improve doctor patient communication in patients with type 2 diabetes mellitus (T2DM). In a previously funded short-term project, #SHP-08-182, the investigators conducted focus groups with patients with T2DM to elicit and understand from the patient perspective, barriers to communicating with their physician. This qualitative work was used in a subsequent pilot project, #PPO-08-402 to refine and pilot test an educational video to encourage patients to use active participatory communication in their visits to physicians. This work was successfully completed and the product is a 10 minute video that in testing was found to be acceptable to patients and feasible for patients to view immediately preceding their medical encounter.

Objectives: In this project the investigators propose to test the effectiveness of the video as an intervention to improved patients' communication. The primary aim is to conduct a randomized controlled trial of an intervention testing whether the intervention increases patients' active participatory communication behaviors, patients' post-visit ratings of self efficacy to communicate, medication adherence, and diabetic control (HgbA1c). There are four secondary aims which include assessments of the (1) mediators, and (2) moderators of the relationship of the intervention condition to outcomes, (3) costs of the intervention, and (4) an evaluation of the feasibility of using the video for pre-visit preparation.

Methods: The investigators will conduct a two group, pre-post, randomized controlled, single-site trial of the intervention in patients with T2DM. The investigators will recruit 156 patients and their physicians for a pre and post-intervention visit. Physicians will be trained with the agenda setting module from the Four Habits model. Patients will be randomized to view a 10 minute intervention or control video prior to their second visit. Visits will be audio recorded and analyzed for patients' and physicians' communication behaviors. Self-efficacy to communicate will be collected by self report. Adherence will be collected by self-report and by medication possession ratio. Diabetic control is collected by chart review. Analyses will evaluate the relationship of the intervention condition to outcomes, mediators and moderators of that relationship, and will estimate costs of the intervention and feasibility of using the video in a busy clinic.

Impacts: VA transformation efforts including interprofessional Patient Aligned Care Teams (PACT) are focusing attention on patient-centered care. Improved communication is a central feature of patient centered care. Communication in medical interactions is critical and plays an important, but often overlooked role in health-care decision making and quality of care. Patients who have difficulty communicating are less involved in consultations with their physician, receive less information and support, and are less satisfied with their care. In turn, these patients may not understand their treatment options, may have less knowledge, less positive beliefs about treatment and less trust in physician, and may experience poorer health outcomes. Teaching patients to communicate more effectively is patient-centered because it inherently supports a patient-driven approach to delivering healthcare. The investigators' intervention is designed to encourage patients' active communication. Improving patients' communication is a unique focus that may supplement and add to the VA efforts in areas such as the Patient Aligned Care Team. In addition, the methodology is not disease specific and may be a paradigm for improvement in other conditions.

Being tested
Intervention Video, Control
Medical subject headings
Diabetes Mellitus

What participants receive

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

  • Intervention VideoBehavioural

    Also called Speak Up!

    A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence

  • ControlBehavioural

    Attention control

Study groups in NCT01671345
Study groupRoleWhat they receive
InterventionActive comparatorPatients randomized to the intervention will view the intervention video
Receives: Behavioral: Intervention Video
ControlPlacebo comparatorPatients randomized to control will view an informative video about nutrition and exercise of similar length
Receives: Behavioral: Control

What is being measured

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

  1. Patients' Perceived Self-efficacy to Communicate

    Communication Self-Efficacy is the degree to which a patient feels able to interact with his/her physician in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. Self Efficacy to Communicate is measured with the Perceived Efficacy in Physician Patient Interactions scale - a valid and reliable self report measure of patients' perceived self efficacy in interacting with physicians. Scores ranging from 5 to 25 are used; higher numbers reflect more perceived self-efficacy in interacting with physicians.

    Measured: at the baseline ( Visit 1) and post-intervention (Visit 2)

  2. Patients Active Participatory Communication Behaviors

    Active Participatory Communication Behavior (collected at visits 1 and 2) is derived from the content of audio recordings of the physician-patient visits.

    Active participatory communication behaviors include four essential elements:

    1. telling a medical history;
    2. asking questions;
    3. being assertive or making requests, and
    4. communication concerns. We coded patients' active participatory communication behaviors from the audio recording by classifying patients' statements into utterances. An utterance is the unit of analysis for coding the different types of behaviors into the communication categories. Utterances are coded according to the categories of active participatory communication behavior. Once classified, communicative behaviors are summed. The higher number means more active communication.

    Measured: at the baseline ( Visit 1) and post-intervention (Visit 2)

Secondary outcomes (2)
  1. Medication Adherence

    Patient adherence to medication was measured with: (1) Medical Outcome Study measure and (2) Morisky scale.

    1. The Medical Outcome Study self-reported adherence to physicians' recommendations scale uses a brief questionnaire that asks whether respondents were adherent to physicians' recommendations and has scores ranging from 25 to 100. Higher numbers reflect better adherence.
    2. The Morisky scale (4-item version) assesses self-reported medication adherence using "yes" or "no" questions to evaluate how a patient feels when they stop taking medication, if they feel hassled about taking medication, and if they have difficulty remembering to take their medication. The scores range form 0 to 4; higher numbers reflect better adherence.

    Measured: Four weeks post-intervention (i.e. four weeks after Visit 2).

  2. Hemoglobin A1c

    Hemoglobin A1c (HgbA1c) is the blood test for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked many times a year in patients with poorly controlled diabetes. Baseline HgbA1c in patients had to be ≥ 7.5.

    Measured: At the baseline (Visit 1) and post-intervention (after Visit 2). All available values were restricted to one year before Visit 1 and from 30 days to one year past Visit 2.

Timeline

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

  1. First posted23 Aug 2012 (estimated)
  2. Study start27 Nov 2013
  3. Primary completion30 Nov 2016
  4. Study completion9 Jan 2017

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
169 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01671345
Sponsor's protocol ID
IIR 12-050
Acronym
ACTIVet
Status last verified
Nov 2018
First submitted
14 Jun 2012
Last updated
11 Mar 2019
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Gordon HS, Street RL. How Physicians, Patients, and Observers Compare on the Use of Qualitative and Quantitative Measures of Physician-Patient Communication. Eval Health Prof. 2016 Dec;39(4):496-511. doi: 10.1177/0163278715625737. Epub 2016 Jan 10.

    PubMed 26755527

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Video in people with Diabetes Mellitus, run by VA Office of Research and Development 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 3 inclusion and 5 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 11 Mar 2019. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Patients' Perceived Self-efficacy to Communicate (time frame: at the baseline ( Visit 1) and post-intervention (Visit 2)). 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 NCT01671345, which also lists 1 linked publication.

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 11 Mar 2019.

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ACTIVet Clinical Trial NCT01671345 | AzTrials