Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized clinical trial (RCT) pilot study as two main objectives:
The investigators hypothesize that adherence, satisfaction, and attrition will be similar for the active intervention group and the attention control group. The investigators also hypothesize that all five dimensions will improve in the intervention group compared to controls over time, and that Cohen's d (Standard Deviation units) will be greater than 0.5 SD units for all five fatigue dimensions at all three post-intervention time points.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep and Rhythm Intervention | Experimental | This arm receives a 4-week behavioral intervention aimed at improving sleep and circadian rhythms, and thereby reducing fatigue. |
|
| Dietary Modifications | Placebo Comparator | This arm receives a 4-week placebo intervention focused on dietary modifications for reducing fatigue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep and Rhythm Intervention | Behavioral |
| ||
| Dietary Modifications |
| Measure | Description | Time Frame |
|---|---|---|
| Morning fatigue severity | self-report ratings of morning fatigue severity (Lee Fatigue Scale) | 3 months |
| Evening fatigue severity | self-report ratings of evening fatigue severity (Lee Fatigue Scale) | 3 months |
| Lack of energy - frequency | self-report rating of the frequency of a lack of energy in past week (single item from Memorial Symptom Assessment Scale) | 3 months |
| Lack of energy - severity | self-report rating of the severity of a lack of energy in past week (single item from Memorial Symptom Assessment Scale) | 3 months |
| Lack of energy - distress | self-report rating of the distress due to a lack of energy in past week (single item from Memorial Symptom Assessment Scale) | 3 months |
| Attrition | Proportion of participants who do not complete the study | 3 months |
| Satisfaction with the intervention | Ratings of participant satisfaction with the 6 intervention components | 3 months |
| Adherence to intervention | Self-reported adherence to each of the 6 behavioral intervention components |
| Measure | Description | Time Frame |
|---|---|---|
| Objectively measured sleep duration | Mean night-time sleep duration in minutes during the 7-day assessment period as estimated by FitBit monitor. | 3 months |
| Objectively measured sleep quality | Mean number of night-time wakes during the 7-day assessment period as estimated by FitBit monitor. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathryn A Lee, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143-0606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31612533 | Derived | Lee KA, Jong S, Gay CL. Fatigue management for adults living with HIV: A randomized controlled pilot study. Res Nurs Health. 2020 Jan;43(1):56-67. doi: 10.1002/nur.21987. Epub 2019 Oct 14. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012890 | Sleep |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
|
| 3 months |
| 3 months |
| Objectively-measured activity | Mean number of daily steps during 7-day assessment period | 3 months |
| Sleep medication use | Self-reported use of sleep medication during the 7-day assessment period | 3 months |
| Self-reported sleep quality | Pittsburgh Sleep Quality Index (PSQI) total score | 3 months |
| Depressed mood | Hospital Anxiety and Depression Scale (HADS) - depression subscore | 3 months |
| Anxious mood | Hospital Anxiety and Depression Scale (HADS) - anxiety subscore | 3 months |
| Physical function | Short Form (SF)-36 physical function score | 3 months |
| Cognitive function | SF-36 cognitive function score | 3 months |
| Medication adherence | AIDS Clinical Trials Group (ACTG) Adherence score | 3 months |
| Daytime sleepiness | Epworth Sleepiness Scale (ESS) - total score | 3 months |
| Fatigue interference with daytime function | Fatigue Severity Scale - mean score | 3 months |
| Sleep behavior | Sleep Behavior Self-Rating Scale (SBSRS) - total score | 3 months |