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Table 2 Study design and characteristics of positive effects on healthcare of DiGA listed in the DiGA directory (as of 02/28/2022).

From: Market access and value-based pricing of digital health applications in Germany

DiGA-Name

Indication(s)

Current listing statusa

Study designb

Patient-relevant improvements of structure and processes a

Medical benefita

Kalmeda

Tinnitus

Final

RCT

tinnitus burden

velibra

Generalized anxiety disorder,

Panic disorder (with/without agoraphobia),

Social phobias

Final

RCT

General mental stress

anxiety symptoms,

depression symptoms

somnio

Insomnia

Final

RCT

insomnia symptoms

Vivira

Back pain

Final

RCT

back pain

zanadio

Obesity

Provisional

RCT

body weight,

body fat distribution,

quality of life

Invirto

Agoraphobia, panic disorder, social phobias

Provisional

RCT

anxiety symptoms,

quality of life

elevida

Fatigue in multiple sclerosis

Final

RCT

fatigue severity

M-sense Migräne

Migraine

Provisional

RCT

Health literacy,

Self–efficacy

migraine burden,

quality of life

Selfapys Online-Kurs bei Depression

Depression

Provisional

RCT

depression symptoms

Rehappy

Stroke

Provisional

RCT

Adherence,

Activities of daily living,

Health literacy,

Self–efficacy

relapse rate,

depression symptoms,

quality of life

deprexis

Depression

Final

RCT

Depression symptoms

Mika

Cancer

Provisional

RCT

Quality of life

Mindable

Agoraphobia, panic disorder

Provisional

RCT

Health literacy,

Anxiety–related control beliefs/

Self–efficacy,

Activities of daily living

Anxiety symptoms,

Panic symptoms,

Quality of life

CANKADO PRO-React Onco

Breast cancer

Provisional

n/a

Health literacy

vorvida

Harmful alcohol consumption,

Alcohol dependence

Final

RCT

Self–efficacy

Alcohol consumption

Selfapys Online-Kurs bei

Generalisierter Angststörung

Generalized anxiety disorder

Provisional

RCT

Anxiety symptoms,

Depression symptoms

Selfapys Online-Kurs bei Panikstörung

Panic disorder

Provisional

RCT

Anxiety symptoms,

Depression symptoms

NichtraucherHelden-App

Tobacco dependence

Provisional

RCT

Smoking prevalence,

Quality of life

ESYSTA App & Portal

Diabetes

Provisional

RCT

HbA1c

Mawendo

knee pain

Provisional

RCT

Knee pain,

Functional state

Oviva Direkt für Adipositas

obesity

Provisional

RCT

Body weight

companion patella

Knee pain

Provisional

RCT

Knee pain,

Functional state

Novego

Depression

Provisional

RCT

Depression symptoms

HelloBetter Stress und Burnout

Stress, burnout

Final

RCT

Stress level

HelloBetter Diabetes und Depression

Depression in diabetes mellitus

Final

RCT

Depression symptoms

Kranus Edera

Impotence of organic origin

Provisional

RCT

Self–management

Erectile function,

Quality of life

HelloBetter ratiopharm chronischer Schmerz

Chronic pain

Provisional

RCT

Pain level

Cara Care für Reizdarm

Irritable bowel syndrome

Provisional

RCT

Work productivity/

Activities of daily living,

health literacy

Irritable bowel symptoms,

Anxiety symptoms,

Depression symptoms,

Quality of life

HelloBetter vaginismus plus

Vaginismus

Final

RCT

Vaginal penetration ability

neolexon aphasie

Aphasia, apraxia

Provisional

RCT

Linguistic skills

  1. RCT: randomized controlled trial
  2. aFinally listed DiGA have already proven their positive effect on healthcare. For provisionally listed DiGA, this evidence is currently still pending.
  3. bFor DiGA with provisional listing (i.e., whose study results are not yet available), study design and postulated benefit are stated as described in the DiGA directory.