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Diabetes Mellitus, Type 2NCT03099928

Developing a Positive Psychology Intervention to Improve Health Behaviors in Type 2 Diabetes: Qualitative Research

An observational study of Diabetes Mellitus, Type 2, run by Massachusetts General Hospital.

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

Specific Aim #1 (Qualitative Research): To identify, through qualitative research, deficits in positive affect and associated barriers to completing health behaviors in type 2 DM patients. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
How many people
31 participants
Where
No sites listed yet
Study dates
1 Mar 2015to 30 Nov 2016
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Type 2 diabetes patients admitted to three inpatient units or seen at the MGH Diabetes Center.

Who may be able to join

  • Adult patients (21 years and older) admitted to one of the inpatient cardiac units (Ellison 9, 10, or11) at MGH or a current outpatient in the MGH Diabetes Center. Patients must have Type 2 Diabetes (confirmed via medical record and diabetologist/attending physician).
  • Suboptimal adherence to health behaviors (diabetic diet, physical activity, medication), as measured by the Medical Outcomes Study Specific Adherence Scale (MOS SAS), as denoted by a score of <15 out of 18.

Who cannot join

  • Cognitive deficits, assessed via a 6-item cognitive screen used to assess appropriate participation of medically-ill patients in research studies.24-26
  • Medical conditions precluding interviews, determined in consultation with attending physician or diabetologist.
  • Inability to communicate in English.

About this study

Specific Aim #1 (Qualitative Research): To identify, through qualitative research, deficits in positive affect and associated barriers to completing health behaviors in type 2 DM patients.

Hypothesis: Patients will be able to complete the structured interview, providing information about their own positive emotional states, identifying strategies to enhance positive emotions, linking the presence of positive emotions to better adherence to health-related behaviors, and identifying additional barriers to completing such behaviors.

Read more

Specific Aim #2 (Creation of intervention): To use the data gathered from qualitative and quantitative measures to create a positive psychology-based intervention

Hypothesis: Using the information provided in this trial, the investigators will be able to create an intervention, composed of several positive psychology exercises, that is well-matched with a diabetic population and is targeted to the enhancement adherence to health-related behaviors in this population. This intervention will then be ready for next stage testing.

Read the detailed description

The investigators are proposing to enroll 31 patients with type 2 DM following an outpatient visit to the MGH Diabetes Center or during admission to Ellison 9-11 inpatient units (or sometime in the following 14 days if the participant is not available to complete the interview after consenting for the study).

For these interviews, the investigators will discuss positive emotional states that patients have experienced and talk about ways they might increase these states. The investigators will also touch on health behaviors in which the patient has engaged and whether positive emotions played a role in completing these behaviors. To enhance the accessibility of this project, the investigators chose to allow patients to complete interviews over the phone. Interactions by phone (rather than in-person visits) can allow for patients who are being discharged from the hospital or have no time to complete the interview during a clinic visit.

The investigators will also conduct a follow up phone call 3 months post-hospitalization during which the investigators will collect mood and anxiety data from participants. The purpose of this data will be to better characterize the population, allowing the investigators to better customize the intervention for this population.

There are two study visits (the first of which can be broken into two parts if the participant cannot complete the interview in the hospital after consenting to the study). The first visit will consist of three brief scales of mood and anxiety (Hospital Anxiety and Depression Scale, Positive and Negative Affect Schedule, and Life Orientation Test-Revised) that will take 10 minutes, followed by a 45 minute interview. Participants also will report their race and ethnicity. The second visit will take place 3 months after the initial visit and will be conducted over the phone. This second visit will consist of the same three brief scales of mood and anxiety.

Baseline Data: Baseline information about enrolled subjects will also be obtained from the patients, care providers, the structured assessments of mood and anxiety symptoms as above, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of cardiac illness, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (admission diagnosis if applicable, HbA1c), medications, length of hospital stay if applicable, and sociodemographic data (age, gender, race/ethnicity, living alone). This information will help the investigators to ensure that the population the investigators recruit is a representative population of patients with type 2 DM.

Qualitative Data: Subjects will undergo an open-ended, one-hour structured interview. The interview will be performed by study staff trained in qualitative research methods by the study PI, Dr. Huffman, using frameworks from Dr. Huffman's prior work. First, subjects will be asked open-ended questions about positive emotional/cognitive experiences. Interviewers will ask about subjects' experience with positive thoughts and feelings recently, and will attempt to elicit both the frequency/intensity of such experiences and the range of such states (e.g., elation vs. optimism). Next, subjects will be asked in an open-ended manner about ideas that they may have to increase the frequency and breadth of their own positive experiences, and then will be asked their opinion about the potential utility of several different existing positive psychology exercises. The interviewers will then inquire about the impact that positive thoughts/feelings may have on our specific diabetes-related health behaviors of interest.

Follow-up 3 Month Phone Call: Three months after discharge from the hospital, a study RA will call subjects to repeat the measures of mood and anxiety completed at baseline (HADS, PANAS, and LOT-R). The investigators will record specific times at enrollment that subjects would prefer to be called (and not to be called) to reduce intrusion on subjects' lives. The investigators will also remind subjects of their upcoming call, in case they need to reschedule. If subjects would rather complete the questions in written form rather than over the phone, the investigators will send them a written packet at the time of each follow-up.

Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

Study groups in NCT03099928
Study groupRoleWhat they receive
Qualitative InterviewsNot described

What is being measured

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

  1. Qualitative data

    Themes related to: Positive psychological states, barriers to health behaviors, relationships between positive states and barriers to health behaviors, and feedback about potential PP exercises

    Measured: Baseline

Secondary outcomes (4)
  1. Change in anxiety

    Measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)

    Measured: Baseline, 3 months

  2. Change in depression

    Measured by the depression subscale of the Hospital Anxiety and Depression Scale (HADS)

    Measured: Baseline, 3 months

  3. Change in positive affective

    Measured by the Positive and Negative Affect Schedule (PANAS)

    Measured: Baseline, 3 months

  4. Change in optimism

    Measured by the Life Orientation Test-Revised (LOT-R)

    Measured: Baseline, 3 months

Timeline

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

  1. First posted4 Apr 2017
  2. Study start1 Mar 2015
  3. Primary completion30 Nov 2016
  4. Study completion30 Nov 2016

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03099928
Sponsor's protocol ID
2014P002578
Status last verified
May 2017
First submitted
29 Mar 2017
Last updated
16 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Massachusetts General Hospital.

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 2 inclusion and 3 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 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

Qualitative data (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 16 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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