Hypertension With Unsatisfactory Sleep Health

Not Applicable

Completed

• Conditions: Insomnia; Hypertension
• Interventions: Behavioral: Brief Behavioral Treatment for Insomnia; Behavioral: Sleep Healthy Using the Internet; Behavioral: Enhanced Usual Care

• Registration Number: NCT02508129
• Lead Sponsor: University of Pittsburgh

Brief Summary

Insomnia and hypertension are common health problems that often occur together and influence each other. This practical, low-cost, clinical trial will evaluate two behavioral treatments for insomnia (a brief intervention with therapist contact and a self-guided Internet intervention) compared to usual care. Participants will be recruited using the electronic health record in their primary care physicians' offices, and will be evaluated for sleep, blood pressure, and health outcomes after 9 weeks, 6 months, and 12 months.

Detailed Description

Insomnia is a prevalent, chronic, and inadequately-treated chronic medical condition associated with comorbid conditions such as hypertension (HTN) and a range of adverse health outcomes. Hypnotic medications are efficacious and widely available, but they have potentially serious adverse effects. Patients and providers prefer non-drug treatments such as Cognitive-Behavioral Treatment of Insomnia (CBT-I), which is safe, efficacious, and durable-but not widely available. Innovative use of electronic health records (EHR) to identify patients, and the availability of new technologies that enable cognitive-behavioral interventions to be delivered at scale, with high treatment fidelity, and at low cost, offer exciting opportunities to address these critical problems. The investigators propose a low-cost, pragmatic, patient-centered, randomized controlled trial comparing two CBT-I-based interventions for insomnia with comorbid hypertension (INS+HTN) to primary care physicians' (PCP) enhanced usual care (EUC). The setting will be University of Pittsburgh Medical Center (UPMC) primary care practices. Participants will be 625 adults with INS+HTN. Recruitment will be conducted using alerts in the EpicCare EHR triggered by patient characteristics (hypertension; hypnotic medications or insomnia diagnosis/problem). The investigators will compare 3 interventions: Brief Behavioral Treatment of Insomnia (BBTI), involving electronic educational material and 4 telephone/web sessions with a live interventionist; "Sleep Healthy Using The Internet" (SHUTi), a self-guided, 8-module, Internet version of CBT-I, with no human contact; and EUC, which includes assessment and educational information for participants and providers. The primary outcome will be self-reported sleep at 9 weeks. Other outcomes include domains of symptoms, health, and patient/provider satisfaction obtained by self-report, home blood pressure monitoring (HBPM), and EHR. Specific Aims for the trial are: (1) To compare interventions on patient-reported symptoms at 9 weeks, 6 months, and 12 months. (2) To compare interventions on health indicators including self-report, HBPM, and EHR measures at 6 and 12 months. (3) To compare patient and provider-level satisfaction with the 3 interventions. (4) Exploratory Aim: To compare BBTI and CBT-I on each outcome domain and intervention adherence/drop-outs.

We made changes to the outcome measures document in April, 2019, and further amended these measures in June, 2019. The reason for these changes was to ensure consistency among the grant application, clinical trial protocol paper, and ClinicalTrials.gov. We made the following specific changes and corrections:

* Insomnia diagnosis, cumulative illness rating scale, and treatment expectations were removed as secondary outcomes, as they are not listed in our protocol as outcome measures. They are only measured at baseline to characterize participants.

* Health-Related Quality of Life "Medical Outcomes Survey Short Form-12 and Client Satisfaction "Client Satisfaction Questionnaire" were changed from primary to secondary outcome measures, to ensure consistency with the grant application and protocol paper.

* Side effects "Treatment-related Side Effects Scale" were changed from a secondary to an "other" outcome measure, again to ensure consistency with the grant application and protocol paper.

The following outcome measures were added to ClinicalTrials.gov to ensure consistency:

Secondary Outcome: Provider Satisfaction "Provider Satisfaction Survey"

Other Prespecified Outcome Measures:

* Daytime Impairment Related to Sleep "PROMIS Sleep Related Impairment"

* Insomnia Severity "Insomnia Severity Index"

* Sleep Quality "Pittsburgh Sleep Quality Index"

* Daytime Sleepiness "Epworth Sleepiness Scale"

* Falls "Side Effect/Falls Questionnaire" "Falls Follow-up Questionnaire"

* Improvement "Patient Global Impression of Improvement Scale"

* Sleep Diary Measures "HUSH Daily Diary"

We also recognized that we had erroneously interpreted "time frame" as the time frame of the instrument itself, rather than the time frame of the assessment battery. Time frames in ClinicalTrials.gov were corrected to capture the time points at which they are assessed, in the following measures:

* Sleep disturbance "PROMIS Sleep Disturbance Scale"

* Health related quality of life "Medical Outcomes Survey Short Form-12"

* Client satisfaction "Client Satisfaction Questionnaire"

* Depression "PROMIS Depression Scale"

* Anxiety "PROMIS Anxiety Scale"

* Fatigue "PROMIS Fatigue Scale"

* Blood pressure "HUSH Sleep Diary"

* Hypnotic use "Health Care Utilization Questionnaire" "HUSH Sleep Diary"

* Health care costs "Health Care Utilization Questionnaire"

* Side effects "Treatment-related Side Effects Scale"

Study Timeline

• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-24
• Study Start: 2015-08
• Primary Completion: 2020-03-05
• Study Completion: 2020-03-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

1. Hypertension diagnosis 'Hypertension diagnosis' is indicated by the presence of at least one of the following:

   1. International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis of essential hypertension in the electronic health record;
   2. Hypertension listed in the medical problem list in the electronic health record.

2. At least one of the following:

   1. Hypnotic on active med list
   2. Insomnia on diagnosis or problem list

3. Age 18 years and up.

4. Meets criteria for DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-5th ed.) Insomnia Disorder

5. At least moderate insomnia severity: Score > 7 on Insomnia Severity Index

6. Telephone, e-mail address, reliable Internet access. 'Reliable internet access' is defined by an individual having a personal e-mail address and having regular internet access within his/her own residence.

7. Stable medical, psychiatric condition

Read More

Exclusion Criteria

1. Untreated current major depression (Patient Health Questionnaire (PHQ-9) score equal to or greater than 15; Generalized Anxiety Disorder (GAD-7) score > 10); patients using stable (3 mos) medication, psychological treatment ARE eligible
2. History of bipolar disorder or psychosis
3. Substance use disorder within past 3 months
4. Dementia or probable dementia diagnosis
5. Active suicidal ideation or psychosis
6. Delayed sleep phase disorder (DSPD) or severe, untreated restless legs syndrome (RLS)
7. Plans to leave present source of care during the following year
8. Non-English speaking, illiterate, or sensory deficits
9. Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
10. Apnea Hypopnea Index (AHI) greater than or equal to 50 or O2 saturation 85% or less for > or = to 10% of the night.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief Behavioral Treatment for Insomnia	Brief Behavioral Treatment for Insomnia	Brief Behavioral Treatment for Insomnia (BBTI) employs behavioral strategies for managing insomnia and is administered in 4 brief weekly contacts with a therapist via online web conferencing.
Sleep Healthy Using the Internet (SHUTi)	Sleep Healthy Using the Internet	SHUTi is an automated, interactive, personalized web-based program for improving insomnia through the use of Cognitive-Behavioral Therapy strategies for insomnia.
Enhanced Usual Care (EUC)	Enhanced Usual Care	EUC involves the primary care physician's current treatment; feedback to patients and providers on assessment and treatment recommendations; an educational video from Emmi Solutions, Inc.

Primary Outcome Measures

Name	Time	Method
Sleep Disturbance	9 weeks	Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance: PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 27-item item bank.; Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of \~20 - \~80. Higher scores indicate greater Sleep Disturbance.

Secondary Outcome Measures

Name	Time	Method
Depression	9 weeks, 6 months, 12 months	The PROMIS Depression Scale is a self-report measure that assesses negative mood, views of self, social cognition, affect and engagement during the past seven days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 28-item bank.; Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of \~20 - \~80. Higher scores indicate greater Depression.
Fatigue	9 weeks, 6 months, 12 months	The PROMIS Fatigue Scale is a self-report measure that assesses the experience and impact of fatigue during the past seven days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 95-item bank.; Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of \~20 - \~80. Higher scores indicate greater Fatigue.
Client Satisfaction	9 weeks	The Client Satisfaction Questionnaire (CSQ) is an 8-item self-report measure that assesses client satisfaction with the services they received.; Scale Range: 24 Minimum Score = 8 (low satisfaction) Maximum Score = 32 (high satisfaction)
Provider Satisfaction	Following closing of recruitment	The provider satisfaction questionnaire is a self-report measure that assesses provider's perceived efficacy of the treatments their patients received, barriers to treatment, and satisfaction of both providers and patients.; Scale Range: 38 Minimum Score: 0 (low satisfaction) Maximum Score: 37 (high satisfaction)
Anxiety	9 weeks, 6 months, 12 months	The PROMIS Anxiety Scale is a self-report measure that assesses fear, anxiousness, and hyperarousal and its associated somatic symptoms during the past seven days. It is administered by computerized adaptive testing (CAT) with individual responses guiding the system's choice of subsequent items from the full 29-item bank.; Scale Range: Item responses are combined to yield a T-score with population mean of 50, standard deviation of 10, and range of \~20 - \~80. Higher scores indicate greater Anxiety.
Health Care Utilization	9 weeks, 6 months, 12 months	The Health care utilization Questionnaire is a self-report measure that asks about recent health care services that have been sought and medications for hypertension and insomnia.; Scale Range: 0 - no limit Minimum Score: 0 (no visits or medications; better) Maximum Score: no limit (multiple visits and/or medications; worse)
Blood Pressure	9 weeks, 6 months, 12 months	Home blood pressures are measured with an Omron BP786 home blood pressure monitor. Reported values for each day in each participant represent the average systolic and diastolic readings and heart rate from 3 measurements. Participants record these values in a 7-day sleep diary. Daily measurements for each participant are averaged across the number of days of recording.; Scale Range: Systolic BP range: 0 - 299; Diastolic BP range: 0 - 299; Heart rate range: 40 - 180. These values represent the reliable ranges for the device. For each variable, higher values are generally considered "worse" and lower values "better." However, very low values (e.g., systolic BP values \<80, diastolic BP values \<60, and HR values \<50) may also indicate poor cardiovascular health.
Hypnotic Use	9 weeks, 6 months, 12 months	Daily hypnotic use is self-reported in a 7-day sleep diary, with the ability to report up to 3 medications taken on a given night.; Scale Range: 22 Minimum Score: 0 (no hypnotic medication use on any day; better) Maximum Score: 21 (multiple hypnotic medications and/or multiple days of use; worse).; Retrospective hypnotic use in past 3 months is self-reported in a demographic and health care utilization questionnaire.; Scale Range: 0 - no limit Minimum Score: 0 (better) Maximum Score: no limit (multiple hypnotic medications and/or multiple days of use; worse).
Health-Related Quality of Life	9 weeks, 6 months, 12 months	The Rand-12 is a 12-item self-report measure that produces physical health (PHC) and mental health (MHC) component scores. T-scores are used and have a population mean of 50.; Scale Range (PHC and MHC): 100 Minimum Score (PHC and MHC) = 0 (worse) Maximum Score (PHC and MHC) = 100 (better)

Trial Locations

Locations (1)

UPMC Health System; 🇺🇸 Pittsburgh, Pennsylvania, United States