Diabetes MellitusTELEHEALTHNCT02522494
Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits
A study testing Pamphlet and Video in people with Diabetes Mellitus, run by VA Office of Research and Development at 3 sites in United States.
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. Poorly controlled diabetes leads to a number of complications including cardiovascular disease, blindness, amputation, and end stage renal disease. 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?
- Pamphlet and Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2016to 31 Mar 2020
- 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 not controlled,
- Adults,
- Age 18 or older
Who cannot join
- Dementia,
- Lives in skilled nursing facility,
- Terminal medical condition,
- Drug-induced diabetes,
- Blind or deaf.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045
Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
Chicago, Illinois, 60611
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
About this study
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. 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. Providers will also receive a pamphlet with specific recommendation to improve communication skills. 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 IOM Report, Crossing the Quality Chasm and is a goal of VA transformation efforts.
Read the detailed description
Background: Clinical video telehealth (CVT) offers the opportunity for more efficient access to high quality primary and specialist care for Veterans. Enthusiasm for CVT is especially high in the VA given geographical separation between many Veterans and their providers at VA Medical Centers. However, because CVT encounters are by nature less personal than in-person visits, communication during CVT visits may be more challenging for both patients and providers resulting in less patient-centered communication. Less personal visits may have less exchange of information, lower satisfaction, less trust, and poorer outcomes. Indeed, research comparing CVT with in-person consultations found that patients in CVT visits were more passive and that CVT interactions were dominated by providers when compared with in-person visits.
This project will leverage prior work from two HSR\&D-funded pilot projects to improve provider - patient communication for Veterans with type 2 diabetes mellitus. In a short-term project, SHP-08-182, the investigators conducted focus groups to elicit and understand patients' barriers to communicating with their providers. This qualitative work was used in a subsequent pilot project, PPO-08-402 to develop an educational video to encourage Veterans to use active participatory communication in their visits to providers. This work was successfully completed and the product is a 10-minute video that, in testing, was found to be acceptable and feasible to show to VA patients immediately preceding their medical encounters.
Objectives: The investigators goal in this project is develop and test a video intervention and to also develop pamphlets for patients and providers to encourage active and positive communication in CVT medical interactions. The investigators goal was developed with and is supported by the project's operational partner the Office of Telehealth Services and is integral to the goal to ensure patient-centered care in new models of care. Patient-centered communication in medical interactions is critical and plays an important, but often overlooked, role in the delivery of health services.
There are two aims. First, the investigators will develop educational interventions to encourage patients and providers to use active communication behaviors during CVT visits. Second, the investigators will conduct a randomized trial of the video and pamphlet (intervention) vs. pamphlet alone (comparison) in a two-arm randomized effectiveness trial. The investigators will evaluate for improvement in visit outcomes including patient and provider measures of patient-centered care and communication, reduction in several common barriers to clinical improvement, and improved medication adherence measures and hemoglobin A1c. In addition, the investigators will assess the mediators and moderators of the relationship of the intervention condition to outcomes.
Methods: The project will have two phases. In the initial phase of the proposed project the investigators will develop the video intervention. Video development will include qualitative interviews with stakeholders and patients regarding CVT barriers and perceived benefits. The investigators will use several existing resources and an expert panel of co-investigators and consultants to bring these elements together and produce the intervention. In phase 2 the investigators will conduct a randomized trial of the intervention, evaluating for improvement in a number of outcomes.
Impacts: The educational tools will be deliverables that could be used prior to CVT visits to improve communication and could serve as a paradigm for developing communication aids for other medical conditions and other clinical settings. The investigators will evaluate whether the educational intervention will help improve communication and will be associated with better visit and intermediate outcomes. Educational tools that encourage more patient-centered communication during CVT encounters may allow more rapid acceptance of CVT, thereby improving access to healthcare and enhancing the operational mission of the project's partner.
- Conditions
- Diabetes Mellitus
- Being tested
- Pamphlet, Video
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamphletBehavioural
Also called Speak Up for Telehealth
An educational intervention delivered prior to patients' visits with primary care physicians.
VideoBehavioural
Also called Speak Up Video for Telehealth
An educational intervention delivered prior to patients' visits with primary care providers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Patients randomized to the intervention will view the video Receives: Behavioral: Pamphlet; Behavioral: Video |
| Pamphlet alone | Other | Patients randomized to the pamphlet alone will only receive the pamphlet Receives: Behavioral: Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
HgbA1c
HgbA1c is regarded as the standard laboratory measurement (blood test) for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked several times a year in patients with poorly controlled diabetes.
Measured: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview). All available values were restricted to one year before Baseline (Pre-Visit Interview) and from 30 days to 6 months past Post-CVT visit Interview.
Communication Self-efficacy
Communication Self-Efficacy (pre and post visit) is the degree to which a patient feels able to interact with his/her provider in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. The Perceived Efficacy in Physician-Patient Interactions scale (PEPPI) is a valid and reliable measure of patients' perceived self-efficacy in interacting with physicians (alpha 0.83). The short form of the PEPPI (PEPPI-5) has 5-items. Score on the PEPPI-5 ranges from 5-25. Higher scores reflect a better perceived self-efficacy in interacting with physicians.
Measured: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week past CVT visit)
Consultation Care Measure (CCM)
Consultation Care Measure (CCM) assesses patient-centered care and patient-centered communication. Patients rate such factors as their providers' (1) communication and partnership, (2) personal relationship, (3) health promotion, (4) positive and clear approach to problem, (5) interest in effect on life on a 21-item scale, each item scores from 1 (strongly disagree) to 5 (strongly agree). Scores can range from 21 to 105. The higher scores mean a better patients' experiences with their provider.
Measured: post-intervention (interview within 1 week after CVT visit)
Adherence (Self-reported)
Self-reported adherence is measured using a brief questionnaire - a general measure of adherence to providers' recommendations and includes 5 items and is scored on a 6-level Likert-type scale ranging from "none of the time" to "all of the time". Scores range from 0-100 (after normalizing the standard 6-30 range) with higher numbers reflecting better adherence. Adherence using this measure is assessed with a brief telephone survey 4 weeks following the visit.
Measured: 4 weeks after the CVT visit
Medication Adherence (MPR)
Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
Measured: 6 months
Adherence at 1 Year
Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
Measured: 1 year
Consultation and Relational Empathy (CARE)
Consultation and Relational Empathy (CARE) Measure - is a tool for measuring patients' perceptions of relational empathy in the consultation. In this 10-item questionnaire patients rate the statements about their doctor's understanding their concern, showing care, and etc. during the recent CVT visit on a scale from 1 to 5 where 1 is "poor" and 5 is "excellent". Scores can range from 10 to 50. The higher score means a better patient's perception of empathy in consultation.
Measured: Post-intervention (interview within one week past CVT visit)
Communication Ratings
The questionnaire assesses patients' ratings of their own participatory communication behavior and patients' ratings of their providers' communication. It is a 15-item scale with 3 sub-scales. Patients' ratings of their (1) providers' informativeness and the extent to which the patient understands that information (information sub-scale) are measured with 5-items; (2) patients' ratings that the provider values and respects them is measured with 5-items; and (3) patients' ratings of their own communication is measured with 5-items. This questionnaire has high internal consistency. The scale is scored from 1 (completely disagree) to 7 (completely agree). The total scores range from 15 to 105. The higher scores indicate a better quality of communication.
Measured: Post-intervention (interview within one week after CVT visit)
Human Connection Scale
Human Connection Scale is a 15-item questionnaire that measures the extent to which patient feel a sense of mutual understanding, caring, and trust with their physicians. The scale is a valid and reliable measure of therapeutic alliance between patients and their physicians. The score from 1 to 4 is used where 1 is "not at all" and 4 is "extremely". The scores range from 15 to 60. The higher scores indicate higher therapeutic alliance between patients and physicians.
Measured: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)
Resistance to Treatment Questionnaire (RTQ)
Resistance to Treatment Questionnaire (RTQ) identifies the reasons for resistance to treatment and its intensity among patients with diabetes. 20-item questionnaire consists of four themes (lack of faith or dissatisfaction, emotional reasons, specific problems, factors connected to despair or failure) containing 5 items each; each item is scored from 1 (strongly disagree) to 5 (strongly agree). The scores range from 20 to 100. The higher scores mean more barriers to treatment (a worse outcome).
Measured: 4 weeks past CVT visit
Secondary outcomes (4)
Trust in Provider Questionnaire
Trust in Provider is an important characteristic of provider-patient relationships and is assessed with a questionnaire. Trust is measured pre- and post-CVT visit using a 9-item measure. The scale is scored on a 7-point Likert scale using the anchors "strongly disagree" and "strongly agree". The scores range from 9 to 63. The higher scores mean a better trust in provider.
Measured: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)
Patient Satisfaction
Patient Satisfaction is assessed as the extent to which the patient is content with the relationship with her/his provider, in terms of the quality of information exchanged during medical encounters, and in terms of the demeanor of the provider toward the patient (courtesy, respectfulness, sensitivity, taking time and not being rushed). This is a 4-item survey, patient's satisfaction is scored from 1 (not at all satisfied) to 7 (extremely satisfied). The scores range from 5 to 35. The higher score indicates a better patient satisfaction.
Measured: four weeks after CVT visit
Participatory Decision-Making
Participatory Decision-Making Style represents the degree to which providers involve patients in decision making. We measure patients' ratings of providers' participatory decision-making style using a 4-item scale evaluated by Heisler et al. in a study of veterans with diabetes. The authors found it to be associated with better patient understanding of diabetes and self-management practices. The survey scores how often provider involves patient in decision-making on a scale from 1 to 5, where 1 is "none of the time" and 5 is "all of the time". Scores range from 4 to 20. Higher scores mean a better outcome.
Measured: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)
Diabetes Self-Efficacy
The investigators used a 4-item scale to measure patients' confidence in their ability to manage their diabetes. The survey scores patients' perception of how well they can handle their diabetes on a scale from 1 to 7, where 1 is "not at all true" and 7 is "very true". The scores range from 4 to 28. The higher score is validated as a predictor of better glycemic control. The higher scores mean a better confidence in managing diabetes.
Measured: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study start1 Jul 2016
- Primary completion31 Dec 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Care provider, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Howard S. Gordon, MD BS, Principal investigator, Jesse Brown VA Medical Center, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522494
- Sponsor's protocol ID
- SDR 12-282
- Acronym
- TELEHEALTH
- Status last verified
- Mar 2022
- First submitted
- 26 Jun 2015
- Last updated
- 4 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gopal RK, Solanki P, Bokhour BG, Skorohod N, Hernandez Lujan DA, Choi W, Gordon HS. Provider, Staff, and Patient Perspectives on medical Visits Using Clinical Video Telehealth: A Foundation for Educational Initiatives to Improve Medical Care in Telehealth. J Nurse Pract. 2021 May;17(5):582-587. doi: 10.1016/j.nurpra.2021.02.020.
PubMed 34471399Gordon HS, Pugach O, Solanki P, Gopal RK. A brief pre-visit educational video improved patient engagement after telehealth visits; results from a randomized controlled trial. PEC Innov. 2022 Sep 5;1:100080. doi: 10.1016/j.pecinn.2022.100080. eCollection 2022 Dec.
PubMed 37213724
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits
- ClinicalTrials.gov ID
- NCT02522494
- Acronym / sponsor ID
- TELEHEALTH / SDR 12-282
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 1 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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. Providers will also receive a pamphlet with specific recommendation to improve communication skills. 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 IOM Report, Crossing the Quality Chasm and is a goal of VA transformation efforts.
Detailed description
Background: Clinical video telehealth (CVT) offers the opportunity for more efficient access to high quality primary and specialist care for Veterans. Enthusiasm for CVT is especially high in the VA given geographical separation between many Veterans and their providers at VA Medical Centers. However, because CVT encounters are by nature less personal than in-person visits, communication during CVT visits may be more challenging for both patients and providers resulting in less patient-centered communication. Less personal visits may have less exchange of information, lower satisfaction, less trust, and poorer outcomes. Indeed, research comparing CVT with in-person consultations found that patients in CVT visits were more passive and that CVT interactions were dominated by providers when compared with in-person visits.
This project will leverage prior work from two HSR\&D-funded pilot projects to improve provider - patient communication for Veterans with type 2 diabetes mellitus. In a short-term project, SHP-08-182, the investigators conducted focus groups to elicit and understand patients' barriers to communicating with their providers. This qualitative work was used in a subsequent pilot project, PPO-08-402 to develop an educational video to encourage Veterans to use active participatory communication in their visits to providers. This work was successfully completed and the product is a 10-minute video that, in testing, was found to be acceptable and feasible to show to VA patients immediately preceding their medical encounters.
Objectives: The investigators goal in this project is develop and test a video intervention and to also develop pamphlets for patients and providers to encourage active and positive communication in CVT medical interactions. The investigators goal was developed with and is supported by the project's operational partner the Office of Telehealth Services and is integral to the goal to ensure patient-centered care in new models of care. Patient-centered communication in medical interactions is critical and plays an important, but often overlooked, role in the delivery of health services.
There are two aims. First, the investigators will develop educational interventions to encourage patients and providers to use active communication behaviors during CVT visits. Second, the investigators will conduct a randomized trial of the video and pamphlet (intervention) vs. pamphlet alone (comparison) in a two-arm randomized effectiveness trial. The investigators will evaluate for improvement in visit outcomes including patient and provider measures of patient-centered care and communication, reduction in several common barriers to clinical improvement, and improved medication adherence measures and hemoglobin A1c. In addition, the investigators will assess the mediators and moderators of the relationship of the intervention condition to outcomes.
Methods: The project will have two phases. In the initial phase of the proposed project the investigators will develop the video intervention. Video development will include qualitative interviews with stakeholders and patients regarding CVT barriers and perceived benefits. The investigators will use several existing resources and an expert panel of co-investigators and consultants to bring these elements together and produce the intervention. In phase 2 the investigators will conduct a randomized trial of the intervention, evaluating for improvement in a number of outcomes.
Impacts: The educational tools will be deliverables that could be used prior to CVT visits to improve communication and could serve as a paradigm for developing communication aids for other medical conditions and other clinical settings. The investigators will evaluate whether the educational intervention will help improve communication and will be associated with better visit and intermediate outcomes. Educational tools that encourage more patient-centered communication during CVT encounters may allow more rapid acceptance of CVT, thereby improving access to healthcare and enhancing the operational mission of the project's partner.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Pamphlet, Behavioral: VideoPatients randomized to the intervention will view the video |
| Pamphlet alone | Other | Behavioral: PamphletPatients randomized to the pamphlet alone will only receive the pamphlet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of type 2 diabetes mellitus,
- Hemoglobin A1c not controlled,
- Adults,
- Age 18 or older
Key exclusion criteria (5 listed)
- Dementia,
- Lives in skilled nursing facility,
- Terminal medical condition,
- Drug-induced diabetes,
- Blind or deaf.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PamphletAlso: Speak Up for TelehealthAn educational intervention delivered prior to patients' visits with primary care physicians. | Behavioural | Intervention, Pamphlet alone |
| VideoAlso: Speak Up Video for TelehealthAn educational intervention delivered prior to patients' visits with primary care providers. | Behavioural | Intervention |
Primary outcome
HgbA1c
Time frame: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview). All available values were restricted to one year before Baseline (Pre-Visit Interview) and from 30 days to 6 months past Post-CVT visit Interview.
HgbA1c is regarded as the standard laboratory measurement (blood test) for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked several times a year in patients with poorly controlled diabetes.
Communication Self-efficacy
Time frame: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week past CVT visit)
Communication Self-Efficacy (pre and post visit) is the degree to which a patient feels able to interact with his/her provider in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. The Perceived Efficacy in Physician-Patient Interactions scale (PEPPI) is a valid and reliable measure of patients' perceived self-efficacy in interacting with physicians (alpha 0.83). The short form of the PEPPI (PEPPI-5) has 5-items. Score on the PEPPI-5 ranges from 5-25. Higher scores reflect a better perceived self-efficacy in interacting with physicians.
Consultation Care Measure (CCM)
Time frame: post-intervention (interview within 1 week after CVT visit)
Consultation Care Measure (CCM) assesses patient-centered care and patient-centered communication. Patients rate such factors as their providers' (1) communication and partnership, (2) personal relationship, (3) health promotion, (4) positive and clear approach to problem, (5) interest in effect on life on a 21-item scale, each item scores from 1 (strongly disagree) to 5 (strongly agree). Scores can range from 21 to 105. The higher scores mean a better patients' experiences with their provider.
Adherence (Self-reported)
Time frame: 4 weeks after the CVT visit
Self-reported adherence is measured using a brief questionnaire - a general measure of adherence to providers' recommendations and includes 5 items and is scored on a 6-level Likert-type scale ranging from "none of the time" to "all of the time". Scores range from 0-100 (after normalizing the standard 6-30 range) with higher numbers reflecting better adherence. Adherence using this measure is assessed with a brief telephone survey 4 weeks following the visit.
Medication Adherence (MPR)
Time frame: 6 months
Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
Adherence at 1 Year
Time frame: 1 year
Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.
Consultation and Relational Empathy (CARE)
Time frame: Post-intervention (interview within one week past CVT visit)
Consultation and Relational Empathy (CARE) Measure - is a tool for measuring patients' perceptions of relational empathy in the consultation. In this 10-item questionnaire patients rate the statements about their doctor's understanding their concern, showing care, and etc. during the recent CVT visit on a scale from 1 to 5 where 1 is "poor" and 5 is "excellent". Scores can range from 10 to 50. The higher score means a better patient's perception of empathy in consultation.
Communication Ratings
Time frame: Post-intervention (interview within one week after CVT visit)
The questionnaire assesses patients' ratings of their own participatory communication behavior and patients' ratings of their providers' communication. It is a 15-item scale with 3 sub-scales. Patients' ratings of their (1) providers' informativeness and the extent to which the patient understands that information (information sub-scale) are measured with 5-items; (2) patients' ratings that the provider values and respects them is measured with 5-items; and (3) patients' ratings of their own communication is measured with 5-items. This questionnaire has high internal consistency. The scale is scored from 1 (completely disagree) to 7 (completely agree). The total scores range from 15 to 105. The higher scores indicate a better quality of communication.
Human Connection Scale
Time frame: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)
Human Connection Scale is a 15-item questionnaire that measures the extent to which patient feel a sense of mutual understanding, caring, and trust with their physicians. The scale is a valid and reliable measure of therapeutic alliance between patients and their physicians. The score from 1 to 4 is used where 1 is "not at all" and 4 is "extremely". The scores range from 15 to 60. The higher scores indicate higher therapeutic alliance between patients and physicians.
Resistance to Treatment Questionnaire (RTQ)
Time frame: 4 weeks past CVT visit
Resistance to Treatment Questionnaire (RTQ) identifies the reasons for resistance to treatment and its intensity among patients with diabetes. 20-item questionnaire consists of four themes (lack of faith or dissatisfaction, emotional reasons, specific problems, factors connected to despair or failure) containing 5 items each; each item is scored from 1 (strongly disagree) to 5 (strongly agree). The scores range from 20 to 100. The higher scores mean more barriers to treatment (a worse outcome).
4 secondary outcomes
Trust in Provider Questionnaire
Time frame: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)
Patient Satisfaction
Time frame: four weeks after CVT visit
Participatory Decision-Making
Time frame: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)
Diabetes Self-Efficacy
Time frame: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34471399Gopal RK, Solanki P, Bokhour BG, Skorohod N, Hernandez Lujan DA, Choi W, Gordon HS. Provider, Staff, and Patient Perspectives on medical Visits Using Clinical Video Telehealth: A Foundation for Educational Initiatives to Improve Medical Care in Telehealth. J Nurse Pract. 2021 May;17(5):582-587. doi: 10.1016/j.nurpra.2021.02.020.
- Derived from this study: PubMed 37213724Gordon HS, Pugach O, Solanki P, Gopal RK. A brief pre-visit educational video improved patient engagement after telehealth visits; results from a randomized controlled trial. PEC Innov. 2022 Sep 5;1:100080. doi: 10.1016/j.pecinn.2022.100080. eCollection 2022 Dec.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard S. Gordon, MD BS principal investigator
Jesse Brown VA Medical Center, Chicago, IL
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pamphlet and Video in people with Diabetes Mellitus, run by VA Office of Research and Development at 3 sites 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 4 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 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 1 Jun 2021). 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?
HgbA1c (time frame: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview). All available values were restricted to one year before Baseline (Pre-Visit Interview) and from 30 days to 6 months past Post-CVT visit Interview.). The study lists 10 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 NCT02522494, 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 4 Aug 2022.